Director/Senior Director, Regulatory CMC
What’s in it for you?
In this role, you will have an opportunity to build the Regulatory CMC function and be a critical member of the Regulatory Leadership Team. You will form close partnerships with members of the pharmaceutical development teams, functional area heads, and other members of senior management. This would impact Mersana by helping to advance assets from early to late stages of development and through major regulatory submissions to commercialization. Regulatory Affairs senior management is committed to developing a robust CMC Regulatory Function within the organization. To be successful you must have an experienced collaborative leadership style with an emphasis on finding innovative solutions to challenging problems. Demonstrated ability to align with key stakeholders across an organization. This roll will report to the Senior Vice President of Regulatory Affairs.
How do you know if you’re the right fit?
You will have the following experience:
- Demonstrable experience developing thoughtful and practical right-sized regulatory strategies.
- Early- and late-stage development experience in a pharmaceutical industry setting.
- Excellent knowledge and understanding of FDA, EMA, ICH guidelines as it relates to CMC and GMP-related issues.
- Experience leading the development of critical dossiers including but not limited to new IMPDs, INDs, and NDAs/BLAs.
- Experience working with fast-paced CMC development programs (e.g., Oncology, Accelerated Approval programs)
- Experience mentoring subject matter experts through dossier writing as well as identification and management of external technical writers.
- Presenting high-level as well as detailed program summaries to executive teams, external development partners, and other key internal and external stakeholders.
- Experience managing others, directly and indirectly.
The other stuff
This is typically a role best suited for a leader with a strong scientific background (advanced degree preferred with minimum BS required) who possess at least 10+ years pharmaceutical industry experience with 6+ years of experience in Regulatory CMC.
- Experience with antibody-drug conjugates is highly desirable
- Candidates with mainly biologics experience should have proficiency with issues pertaining to small-molecule drugs as well
Position is eligible for bonus, option awards and benefits including medical, dental and life insurance, 401(k) participation, vacation, and paid holidays.
Successful candidate must be authorized to work in the United States.
Mersana Therapeutics, Inc. is an equal opportunity employer.