Manager of Regulatory Affairs Details

Manager of Regulatory Affairs

The Talent State - Remote

Employment Type : Full-Time

Job Description:
Manager of Regulatory Affairs
Pharmaceutical Chemistry, Manufacturing and Controls

The Company - Client:
A young, dynamic, entrepreneurial, and growing regulatory and technical consulting firm providing
specialized consulting and contracting services in the areas of Chemistry, Manufacturing and Controls
(CMC) for biopharmaceutical companies (small molecule and biologic products)
Adept in developing risk-based CMC strategies following cGMP for 21st Century initiatives and Quality
by Design (QbD) principles
Distinguish ourselves by our passion for creativity and innovation
Offer flexible work environment allows for on-site, off-site, and virtual-office scenarios
Clients include national and multinational pharmaceutical companies

The Candidate:
Client, CMC Consulting is seeking an exceptional science professional to join our Regulatory
Affairs team. The candidate will be responsible for supporting our Biotechnology/Pharmaceutical clients
throughout the regulatory filing process, including serving as the client lead as Manager of Regulatory
Affairs. A successful candidate will have a proven track record of learning and applying scientific principles
to solve CMC technical and project management challenges. Seeking a passion to help patients by enabling
the expeditious development and approval of high-quality, life-saving medicines.

Required Activities/Experience:
MS in Chemistry, Biology, Chemical Engineering, Pharmacy, Healthcare, Public Health, or a
related field.
5+ years’ experience in the Authoring and review of CMC sections for NDA, BLA, IND, and IMPD
Creation and authoring of global and regional dossiers (IND, IMPD, and Canadian QOS).
Coordinate timely & accurate assembly of responses to inquiries from the FDA on CMC content
Strategize regulatory CMC pathway for new small & large molecules
Assess and strategize post-approval changes and relevant submission
Authoring CMC amendments, supplements, and annual reports
Preparing briefing documents for the health authority meetings
Regulatory agency meeting support including meeting preparation and briefing document
creation.
Review of analytical test methods, specifications, and stability protocol/report/data
Support and prepare other CMC ad-hoc requests at the pre & post-approval stage of the
product
Coordinate timely & accurate assembly of responses to inquiries from the FDA on CMC content
Sponsor consultancy regarding drug development including timeline management

Critical success factors:
Ability to work with diverse stakeholders, both internally and at commercial contract manufacturers.
Strong knowledge and demonstrated practice of cGMP.
Detail-oriented with strong written and oral communication skills and proven history of working with
others in a multidisciplinary team environment.
Ability to troubleshoot problems, work within a team, and independently design, develop, and
execute experiments.
Ability to manage several projects simultaneously, creative in developing strategies for solving
problems, and is driven by project requirements such as milestones and timelines.

Job Type: Full-time

Pay: $105,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift

Supplemental Pay:

• Bonus pay
• Commission pay
• Signing bonus
• Tips

Experience:

• Authoring and reviewing: 4 years (Required)
• NDA, BLA, IND, and IMPD: 5 years (Required)

Work Location:

• Fully Remote

Benefit Conditions:

• Only full-time employees eligible

Work Remotely:

• Yes