Director, Regulatory Affairs, Immunology & Respiratory TA Lead
- Full-Time
- King Of Prussia, PA
- CSL Behring
- Posted 4 years ago – Accepting applications
Job Description
With operations in 35+ nations and ~ 27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
The Global Regulatory Affairs (GRA) Region North America, Therapeutic Area Lead (TA Lead) is a member of the GRA Region North America Leadership Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by:
Leading and overseeing GRA Region North America regulatory teams for assigned therapeutic area.
Leading the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve as the CSL Behring primary contact for health authorities for products within the portfolio.
Driving and executing comprehensive, commercially and globally aligned regulatory activities/strategies within the region for CSL Behring's product portfolio throughout development and after commercialization.
Assuring a productive collaboration with key internal stakeholders, such as Regional commercial operations and affiliate regulatory affairs, to ensure successful development, strategic alignment and execution of regional regulatory strategies that result in successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions.
Contributing to Regional regulatory intelligence to account for changes in relevant regulations / laws impacting CSL Behring's business within GRA Region North America and assesses these changes for impact to the business and CSL Behring's product portfolio. May represent CSL Behring on Industry forums.
Collaborating and aligning with GRA functional TA & Site Leads, as appropriate, including exchanging information on relevant topics. Act as the regional representative for the GRA Therapeutic Area Team(s) for assigned therapeutic area(s).
In limited situations, may act as regional representative for specific development projects to Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy.
Reporting Relationships:
Role that this position reports to: Head, GRA Region, North America
Roles that may report to this position:
Regional Senior Regulatory Manager, Region, North America
Regional Regulatory Manager, Region North America
Regional Regulatory Scientist, Region North America
Regional Regulatory Specialist, Region North America
Main Responsibilities and Accountabilities:
1. Works closely with the Head, GRA Region to maintain an effective, globally minded, Global Regulatory Affairs organization that is focused on utilizing creative problem solving skills, can clearly articulate the regional regulatory perspective to stakeholders, regardless of level, and supports effective GRAST teams for assigned therapeutic area. Contributes to GRA Region Leadership Team (GRA RLT).
2. Accountable for CSL Behring's relationship with respective health authorities within the region. Ensures high quality working relationships are established and/or maintained with regional health authorities and negotiates with these authorities to achieve positive outcomes for CSL Behring. Leverages global GRA functions to support this objective, as appropriate.
3. Provides a global mindset and expertise in Regulatory Affairs to ensure that emerging trends/issues are addressed by utilizing creative problem solving skills, and proactively influences the regional regulatory strategy in alignment with the global regulatory strategy.
4. Drives and executes comprehensive, commercially and globally aligned regulatory activities within the region for assigned therapeutic area throughout development including timely and successful registration of new products and maintenance of existing products. Ensures understanding and regional alignment of regulatory activities amongst the GRA Region staff.
5. Empowers and advises the members of GRA Region Therapeutic Area to ensure that the project portfolio objectives are met within the region. Additionally, provide strategic and tactical regulatory leadership and guidance for Regional Regulatory Senior Managers/Managers, Regulatory Scientists/Specialists, as appropriate.
6. When acting as a regional representative to GRAST, provide regional regulatory perspective, advocate and drive the 'one GRA' perspective with team stakeholders.
7. Enables growth and professional development of the GRA Region team members, including succession planning for critical roles with GRALT. Ensures all team members have been trained on their role.
8. Responsible to interact with therapeutic area / site leads for all of GRA functions on a regular basis to assure the delivery of innovative and competitive solutions to accelerate program development, reduce risks and increase success rate.
9. Responsible to interact with key internal stakeholders, such as Regional Commercial Operations and affiliate regulatory affairs, on a regular basis to ensure delivery of successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions.
10. Implements and maintains global regulatory processes and operations for GRA Region. Implement/utilize electronic systems in line with GRA Operational Excellence. Ensures all team members have been trained.
11. Represents CSL Behring on industry forums to drive changes in the regulatory environment, as appropriate. Fosters regulatory intelligence for data generated within CSL Behring, specifically in GRA Region North America
Leadership
Manage the Regional regulatory activities in alignment with the Global Regulatory Affairs activities.
Driving Performance
Sets clear expectations/objectives aligned with CSL Company Objectives
Provides an appropriate balance of direction and support to manage the performance of direct reports
Holds people accountable for their performance and coaches individuals as needed to ensure they contribute at the right level
Evaluates performance, gives feedback and recognizes results
Ensures operational efficiencies that contribute to our bottom line
Building Productive Teams
Partners with Human Resources to select and onboard highly-qualified candidates (both internal and external) for open positions
Builds a productive, engaging team culture and climate based on trust, respect, and mutual support
Clarifies team roles, goals, mission, and ground rules
Builds networks with other CSL teams to support business objectives ("One CSL")
When required, uses appropriate approaches to build virtual, cross-cultural, and/or cross-functional teams
Developing People
On-boards new hires
Recognizes and develops the potential of direct reports
Holds professional development and career discussions with direct reports
Provides opportunities for team members to learn and grow
Develops self
Creating the Future
Serves as a role model for CSL's Values
Lives CSL's mission, vision, and strategy and develops action plans to drive strategy execution
Is dedicated to fulfilling the needs of internal and external customers and stakeholders
Challenges the status quo; fosters innovation and continuous improvement
Applies business acumen skills to help grow the business
Position Qualifications and Experience Requirements:
Education
A bachelor's degree in Science or Pharmacy; post-graduate degree is advantageous.
Experience
At minimum 10 years' experience in the pharmaceutical industry, preferably in Biologics/Research & Development/Regulatory Affairs. Some experience may be accounted for with advanced degree.
At least 7 years of regulatory experience and experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience.
Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities.
Experience in leading negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes.
Experience working with external stakeholder bodies, e.g. trade associations is advantageous.
Demonstrated experience in working in a complex and matrix environment with multiple stakeholders is required.
Competencies
Strong ethics and integrity.
Think strategically and develop regional regulatory strategies to enable successful regional regulatory approvals in alignment with the global regulatory strategy.
Leadership ability with demonstrated problem solving and decision making skills.
Strong team player with the communication and organizational skills to interact seamlessly both internally and externally on strategic regional regulatory matters.
A balanced technical understanding of products and processes combined with superior business, regulatory and compliance acumen.
Ability to develop constructive and effective relationships with direct reports, colleagues and senior management.
Proven ability to build and lead effective, well integrated, collaborative teams, empowers others.
Cross cultural sensitivity demonstrating understanding and acceptance of different cultural parameters.
Fluency in English (verbal and written).
Worker Type:
Employee
Worker Sub Type:
Regular
Apply to this Job
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
The Global Regulatory Affairs (GRA) Region North America, Therapeutic Area Lead (TA Lead) is a member of the GRA Region North America Leadership Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by:
Leading and overseeing GRA Region North America regulatory teams for assigned therapeutic area.
Leading the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve as the CSL Behring primary contact for health authorities for products within the portfolio.
Driving and executing comprehensive, commercially and globally aligned regulatory activities/strategies within the region for CSL Behring's product portfolio throughout development and after commercialization.
Assuring a productive collaboration with key internal stakeholders, such as Regional commercial operations and affiliate regulatory affairs, to ensure successful development, strategic alignment and execution of regional regulatory strategies that result in successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions.
Contributing to Regional regulatory intelligence to account for changes in relevant regulations / laws impacting CSL Behring's business within GRA Region North America and assesses these changes for impact to the business and CSL Behring's product portfolio. May represent CSL Behring on Industry forums.
Collaborating and aligning with GRA functional TA & Site Leads, as appropriate, including exchanging information on relevant topics. Act as the regional representative for the GRA Therapeutic Area Team(s) for assigned therapeutic area(s).
In limited situations, may act as regional representative for specific development projects to Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the development and delivery of innovative, science-based, solution-oriented, and globally aligned regulatory strategy.
Reporting Relationships:
Role that this position reports to: Head, GRA Region, North America
Roles that may report to this position:
Regional Senior Regulatory Manager, Region, North America
Regional Regulatory Manager, Region North America
Regional Regulatory Scientist, Region North America
Regional Regulatory Specialist, Region North America
Main Responsibilities and Accountabilities:
1. Works closely with the Head, GRA Region to maintain an effective, globally minded, Global Regulatory Affairs organization that is focused on utilizing creative problem solving skills, can clearly articulate the regional regulatory perspective to stakeholders, regardless of level, and supports effective GRAST teams for assigned therapeutic area. Contributes to GRA Region Leadership Team (GRA RLT).
2. Accountable for CSL Behring's relationship with respective health authorities within the region. Ensures high quality working relationships are established and/or maintained with regional health authorities and negotiates with these authorities to achieve positive outcomes for CSL Behring. Leverages global GRA functions to support this objective, as appropriate.
3. Provides a global mindset and expertise in Regulatory Affairs to ensure that emerging trends/issues are addressed by utilizing creative problem solving skills, and proactively influences the regional regulatory strategy in alignment with the global regulatory strategy.
4. Drives and executes comprehensive, commercially and globally aligned regulatory activities within the region for assigned therapeutic area throughout development including timely and successful registration of new products and maintenance of existing products. Ensures understanding and regional alignment of regulatory activities amongst the GRA Region staff.
5. Empowers and advises the members of GRA Region Therapeutic Area to ensure that the project portfolio objectives are met within the region. Additionally, provide strategic and tactical regulatory leadership and guidance for Regional Regulatory Senior Managers/Managers, Regulatory Scientists/Specialists, as appropriate.
6. When acting as a regional representative to GRAST, provide regional regulatory perspective, advocate and drive the 'one GRA' perspective with team stakeholders.
7. Enables growth and professional development of the GRA Region team members, including succession planning for critical roles with GRALT. Ensures all team members have been trained on their role.
8. Responsible to interact with therapeutic area / site leads for all of GRA functions on a regular basis to assure the delivery of innovative and competitive solutions to accelerate program development, reduce risks and increase success rate.
9. Responsible to interact with key internal stakeholders, such as Regional Commercial Operations and affiliate regulatory affairs, on a regular basis to ensure delivery of successful applications for assigned therapeutic area, from early development to Marketing Authorization (MA), and for any post MA submissions.
10. Implements and maintains global regulatory processes and operations for GRA Region. Implement/utilize electronic systems in line with GRA Operational Excellence. Ensures all team members have been trained.
11. Represents CSL Behring on industry forums to drive changes in the regulatory environment, as appropriate. Fosters regulatory intelligence for data generated within CSL Behring, specifically in GRA Region North America
Leadership
Manage the Regional regulatory activities in alignment with the Global Regulatory Affairs activities.
Driving Performance
Sets clear expectations/objectives aligned with CSL Company Objectives
Provides an appropriate balance of direction and support to manage the performance of direct reports
Holds people accountable for their performance and coaches individuals as needed to ensure they contribute at the right level
Evaluates performance, gives feedback and recognizes results
Ensures operational efficiencies that contribute to our bottom line
Building Productive Teams
Partners with Human Resources to select and onboard highly-qualified candidates (both internal and external) for open positions
Builds a productive, engaging team culture and climate based on trust, respect, and mutual support
Clarifies team roles, goals, mission, and ground rules
Builds networks with other CSL teams to support business objectives ("One CSL")
When required, uses appropriate approaches to build virtual, cross-cultural, and/or cross-functional teams
Developing People
On-boards new hires
Recognizes and develops the potential of direct reports
Holds professional development and career discussions with direct reports
Provides opportunities for team members to learn and grow
Develops self
Creating the Future
Serves as a role model for CSL's Values
Lives CSL's mission, vision, and strategy and develops action plans to drive strategy execution
Is dedicated to fulfilling the needs of internal and external customers and stakeholders
Challenges the status quo; fosters innovation and continuous improvement
Applies business acumen skills to help grow the business
Position Qualifications and Experience Requirements:
Education
A bachelor's degree in Science or Pharmacy; post-graduate degree is advantageous.
Experience
At minimum 10 years' experience in the pharmaceutical industry, preferably in Biologics/Research & Development/Regulatory Affairs. Some experience may be accounted for with advanced degree.
At least 7 years of regulatory experience and experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience.
Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (respective) regional Regulatory Authorities.
Experience in leading negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes.
Experience working with external stakeholder bodies, e.g. trade associations is advantageous.
Demonstrated experience in working in a complex and matrix environment with multiple stakeholders is required.
Competencies
Strong ethics and integrity.
Think strategically and develop regional regulatory strategies to enable successful regional regulatory approvals in alignment with the global regulatory strategy.
Leadership ability with demonstrated problem solving and decision making skills.
Strong team player with the communication and organizational skills to interact seamlessly both internally and externally on strategic regional regulatory matters.
A balanced technical understanding of products and processes combined with superior business, regulatory and compliance acumen.
Ability to develop constructive and effective relationships with direct reports, colleagues and senior management.
Proven ability to build and lead effective, well integrated, collaborative teams, empowers others.
Cross cultural sensitivity demonstrating understanding and acceptance of different cultural parameters.
Fluency in English (verbal and written).
Worker Type:
Employee
Worker Sub Type:
Regular