Duration: 6 months (we would like to start with 6 months, with the potential to extend if the person is highly competent and a good resource for our team)
Location: Remote but preference is to have a candidate available to be onsite at the Foster City, CA offices 2-3 days if possible
- Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products. Extensive interaction with departments outside of CMC Regulatory Affairs to define strategy and submission plans. Ensure dossiers meet ICH and local regulatory requirements.
- Act as the regional CMC Regulatory lead for assigned products and territories within a global matrix team, contributing to global CMC regulatory strategies for the International markets.
- Liaise with colleagues in Regulatory Affairs therapeutics teams, local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines.
- Co-ordinate regulatory assessments for post-approval CMC changes, develop filing strategy and plans for assigned markets and execute filings according to agreed priorities.
- Maintain a current awareness of CMC registration requirements in each of the International regions and communicate key regulatory intelligence to the organization on a timely basis.
Knowledge, Experience and Skills:
- BA/BS, MS or Ph.D or equivalent education.
- Significant experience in Regulatory Affairs CMC and/or relevant pharmaceutical industry experience
- Experience in the preparation of CMC components of MAA or post-approval variation submissions for small molecule and/or biologics products.
- Biologics experience or drug-device combination product experience would be an advantage.
- A proven ability to co-ordinate the preparation of a variety of CMC regulatory documents in collaboration with other functions.
- Proven strategic thinking skills, with a proven track record for developing global CMC regulatory strategies in multiple markets simultaneously.
- An in-depth knowledge of ICH and regional CMC regulatory requirements, and an understanding of current global and regional trends in CMC Regulatory Affairs.
- Experience representing CMC regulatory affairs on regulatory and cross functional teams.
- Excellent written and verbal communication skills.
Required Years of Experience: At least 2 – 3 years of experience
Top 3 Required Skill Sets: Significant experience in CMC Regulatory Affairs; strong verbal and written communication skills; experience in leading and preparation of regulatory submissions
Top 3 Nice to Have Skill Sets: Experience with Veeva Vault, including RIM; global regulatory expertise
Required Degree or Certification B.A/B.S, MS or Ph.D or equivalent education
Any Disqualifiers? Insufficient regulatory experience that prevents the candidate from acting as an effective lead for assigned product(s) and regulatory submissions.
