REMOTE Director - CMC Regulatory REMOTE Director - CMC Regulatory - Skills Required - Regulatory Affairs Certification (RAC), pharmaceutical drug development, CMC Regulatory, Management/Supervisory Role, Small Molecule Products, US and International CMC Regulatory Requirements, Preparation of Module 3 (CMC Sections), Late State Development/Commercialization, NDAs/MAAs/INDs, CMC Submissions with FDA/EMA
We are a clinical stage biopharm company founded in 2013. We are focused on developing and commercializing therapies to treat targeted patient populations suffering from serious diseases with a high unmet medical need.
We are looking for experienced individuals to join our team for a variety of roles. These roles are remote with excellent compensation packages.
Top Reasons to Work with Us
- REMOTE opportunity
- Breakthrough therapies
- Great time to join the company
Reporting to the Head of Regulatory Affairs
- Oversee all global and US CMC regulatory support and submissions for late stage development and commercial products.
- Implement regulatory strategies and prepare the submission of CMC sections, marketing application, supplement and variations.
- Interface with Manufacturing, Supply Chain, Quality, CMOs and other strategic partners.
- Oversee the development and implementation of CMC regulatory strategies.
- Identify Risks and propose plans to mitigate risks.
- Plan, prepare, review CMC components of briefing packages in connection with health authority scientific advice and (pre-)submission meetings.
- Maintain a high-level understanding of global (ICH, FDA, EMA) regulatory requirements.
- Lead negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators.
- Bachelor's Degree minimum - Chemistry/Biology or Pharmaceutical Science
- 10+ Years' Pharmaceutical Drug Development experience
- 5+ Years' Hands-on CMC regulatory experience
- Management/Supervisory experience
- Solid working knowledge of late stage development and commercialization of pharmaceuticals
- Firsthand experience in development of small molecule products and preparation of Module 3 (CMC sections) of NDAs, MAAs, and INDs.
- Managing successful CMC submissions with FDA/EMA and demonstrated evidence of writing regulatory documents for both development and commercial products
- Willing to travel, both domestic and internationally up to 20% percent of the time
Competitive Compensation and Benefits
Bonus up to 20%
PTO and Holidays
So, if you are an Regulatory CMC candidate with supervisory experience, please apply today!
Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
REMOTE Director - CMC Regulatory