Dova is currently recruiting an Associate Director, CMC Regulatory Affairs to join our team in Durham, NC. In the role, you will lead worldwide CMC regulatory activities for assigned products. Collaborates with functional areas to ensure sound regulatory CMC strategy. Provides regulatory guidance on quality related issues. Provide the best possible CMC regulatory strategies that integrate with plans for other disciplines and company objectives. Timely and accurate preparation and review of regulatory submission and related CMC documents.
- Functions as regulatory CMC lead for assigned products and territories
- Provides strategic CMC regulatory interpretation and guidance to project teams from early development through post-approval
- Facilitate and deliver the regulatory strategy to support the lifecycle of the asset (accountable for execution of CMC aspects).
- Determine from a strategic and scientific perspective the content of relevant CMC sections (technical and/or procedural) of project/product specific documents submitted to regulatory agencies (e.g. NDA, MAA, INDs, IMPDs, etc.) and ensure that these documents meet high scientific standards and regulatory requirements.
- Participate in project/product-related discussions and provide strategic, scientific and regulatory input, for CMC regulatory and/or procedural aspects
- Oversees creation of and updates to quality sections of regulatory filings
- Compile/write/review high quality project/product specific CMC regulatory documents to be submitted to regulatory agencies for CMC and ensure that those documents meet regulatory requirements.
- Plan and lead CMC regulatory activities associated with FDA meetings pertaining to a project/product
- Provide support to other regulatory team members/leadership for key regulatory activities pertaining to a project/product
- Reviews quality submission documents to ensure consistency with related filings and regulatory requirements
- Interacts with manufacturing and quality groups, regulatory agencies, contract and partner organizations, as necessary, regarding CMC regulatory issues
- Assess impact of manufacturing changes pertaining to approved commercial products
- Ensure planning, proper organization and execution of CMC regulatory activities in line with the overall project plan and regulatory affairs milestones
- Be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).
- 12+ years of experience in the pharmaceutical/biotech or related industry
- 10+ years of experience in the pharmaceutical/biotech or related industry
- 7+ years in regulatory CMC function
- Diverse experience including drugs, biologics, and international filings would be useful for this position
- Proficiency with document management applications and MS Office. Familiarity with operational systems (e.g., TrackWise, LIMS, Master Control)
- Occasional travel to other locations, partner organizations, regulatory agency meetings, or industry meetings may be required
- Bachelor’s degree in a science related field; advanced degree preferred
Why Join Us?
With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that. At our Durham office, we provide a sleek and high-tech work environment with glass walls and adjustable desks. All employees are issued laptops, have access to a stocked kitchen, and are included in Free Lunch Fridays! We also offer a competitive benefits package, to support the health and happiness of our staff.
An Equal Opportunity Employer
Dova is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Dova are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.