Sr. Manager/Associate Director, Regulatory Affairs CMC
Salary: ($140,000-$180,000)
Madison, WI
This publicly traded clinical stage biopharmaceutical company develops medicines that treat intractable diseases by silencing the genes that cause them. They have 3 products in late phase 3, and 12 other products close behind. The company is currently looking for a Senior Manager/Associate Director CMC to help head up this company's combination products division - this person will be working directly with the Executive Director, Regulatory Affairs CMC
Responsibilities:
- Create and evaluate comprehensive CMC sections for INDs, CTAs, IND annual reports, NDA, and MAA submissions.
- Analyze and convey CMC regulatory prerequisites to guarantee adherence to relevant regulations and guidelines throughout the development process.
- Oversee and ensure adherence to all reporting obligations, including annual and periodic reports.
- Offer regulatory assistance and direction to multiple departments, programs, and teams, with a strong focus on frequent interactions with technical teams.
- Examine technical documentation to verify compliance with existing regulatory applications and approvals.
- Conduct in-depth research and analysis of regulatory information, maintaining up-to-date knowledge of current regulatory landscape.
An ideal candidate for this role will have:
- Bachelor's degree in biochemistry, chemistry, biology, or a related field within the pharmaceutical domain. An advanced degree is preferred.
- A minimum of 3-5 years of experience in CMC regulatory affairs and 5-8 years in the pharmaceutical industry, including serving as a regulatory lead for drug-device combination products. International experience is highly desirable (or equivalent).
- Proven track record of providing strategic regulatory guidance for drug-device combination products and device development, registration, and post-market support teams.
- Familiarity with ICH and FDA guidelines pertinent to device and combination product CMC aspects of product development.
- Capable of effectively managing complex projects and adhering to timelines within a collaborative matrix team environment.
This firm greatly values its employees as seen through their compensation packages:
- 401(k) matching
- Equity
- 3 weeks PTO
- Health/Life insurance
If you're interested in this role, please apply now!
