Regulatory-CMC consultant - Biologic
San Diego Metro Area, California
Responsibilities will include, but are not limited to, the following:
1. Responsible for the development of the CMC regulatory strategy for submissions. These submissions include IND/CTA/BLA, NDA, CTD and MAA regulatory filings.
2. Lead the preparation and review CMC submission documents, registration dossiers, health authority briefing packages, and responses to health authorities with other relevant line functions.
3. Interact with regulatory agencies and represent Regulatory CMC at regulatory agency meetings. Prepare SMEs for health authority meetings as required.
4. Responsible for the management of CMC activities related to specific developmental or commercial compounds.
5. Responsible for the regulatory evaluation of CMC change controls.
6. Represent Regulatory CMC on cross-functional teams such as GPDO development/commercial and Regulatory Affairs teams.
7. Take a leadership role in the CMC development/commercial teams.
8. Maintain knowledge of global regulatory environment, regulations and procedures.
Must have experience with CMC regulatory documents (NDA, MAA, CTD, BLA, supplements, responses and IND/CTAs)
Experience in the development of CMC regulatory strategy with a focus on BLA and global biologic marketing applications.
Thorough knowledge of FDA, EMEA and ICH guidelines.
Knowledge of rest of world pre- and post-approval guidelines
Have a solution-oriented approach to problem solving
Expertise in the biologic drug development process and post approval activities
Ability to work on complex projects and within cross-functional teams
Prior supervisor or project management experience
Experience with global CMC regulations for biological compounds.
PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with
a minimum of 7 years in the pharmaceutical industry, and a minimum of 5 years CMC regulatory (biologics preferred) experience.