Associate Director, Regulatory CMC

Location
Rensselaer, New York, United States of America
Posted
Jul 15, 2021
Ref
23724BR
Required Education
Bachelors Degree
Position Type
Full time
The Associate Director of CMC RA will provide strategic management and leadership to support the Regeneron portfolio products assigned. The candidate will be responsible for assuring development and execution of regulatory strategies for biologic products and combination products in the US & EU and manage 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:
  • Responsible for managing 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 filling documents (e.g. pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, DSUR, amendments, supplements).
  • Lead and facilities activities, including team preparation, for meetings with FDA and other regulatory authorities for CMC development 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
  • Perform RA-CMC compliance activities to support IOPS organization.
  • Coordinate and lead regulatory inspections, as needed, at the Rensselaer site or at other sites if the inspection relates to regulatory CMC issues.
  • Montior emerging legislation and guidance in the CMC field and contribute to ensuring company-level awareness and compliance (where appropriate).
  • Lead and mentor direct reports and/or junior staff members
This role might be for you if:

Need to have good understanding of current CMC RA worldwide regulations.

Proven track record of supporting biological product 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 and negotiation skills

We expect you to build collaboration and teamwork across cross functional teams

Demonstrated skill in managing multiple priorities

We seek a minimum of 10 years pharmaceutical/biotech industry experience including a minimum of 5 years of relevant CMC experience

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.