The Director of RA CMC will provide strategic management and leadership to support the Regeneron portfolio of products assigned. Specifically, this new role will include CMC regulatory leadership on gene therapy products. The candidate will be responsible for assuring development and execution of regulatory strategies for drug products and combination products in the US & EU and lead the activities of other CMC regulatory affairs staff or contract regulatory support in the performance of the duties outlined below.
In this role, a typical day might include the following:
This role might be for you if:
- Responsible for leading activities of assigned Regulatory Affairs CMC team with emphasis on global regulatory strategy and the preparation, review and submission of documents for FDA and other regulatory authorities.
- Supports the regulatory function on assigned development/commercial programs providing CMC regulatory guidance and strategy including identifying and assessing regulatory risks.
- Critically review and provide strategy input on regulatory filing documents (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements).
- Lead and facilitate activities, including team preparation, for meetings with FDA and other regulatory authorities for CMC development/commercial activities.
- Liaison responsible for communication with FDA and other regulatory authorities for assigned programs .
- Proactively identify program issues and develop appropriate regulatory strategies to mitigate risks to filings.
- Perform RA-CMC compliance activities to support IOPS organization.
- Coordinate and manage regulatory inspections, as needed, at the Rensselaer site or at other sites if the inspection relates to regulatory CMC issues.
- Monitor emerging legislation and guidance in the CMC field and contribute to ensuring company-level awareness and compliance (where appropriate).
- Manage and mentor direct reports and/or junior staff members.
- Need to have good understanding of current CMC RA worldwide regulations.
- Must have a working familiarity with molecular biology techniques related to gene therapy, RNAi, or oligonucleotide products.
- Proven track record of supporting gene therapy, oligonucleotide, or RNAi products through development and approval is a distinct advantage.
- Experience managing and developing staff members essential.
- Experience in dealings with FDA and other regulatory authorities.
- Strong communication skills.
- Ability to build collaboration and teamwork across cross functional teams.
- Demonstrated skill in managing multiple priorities.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
This job has expired.