Address
Form of work Responsibilities:
- Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings.
- Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
- Responsible for the Global Regulatory evaluation of CMC change controls with supervision.
- Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
- Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams.
- Participate in Global Regulatory interactions with health authorities, with supervision.
- Facilitate document review meetings and discussions.
- Develop and maintain knowledge of regulatory environment, regulations and procedures.
Requirements:
- BS/BA degree in Scientific Discipline (Masters or higher preferred) with
- 5-7 years in the pharmaceutical industry, preferably with 1-3 years CMC regulatory experience.
- Experience with sterile products preferred.
- Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents)
- Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations
- Experience in drug development processes and post-approval requirements
- Experience in developing CMC regulatory strategy
- Experience in project management
- Have a solution-oriented approach to problem solving
- Ability to plan/prioritize work of group members and guide/develop others.
- Ability to work on complex projects and within cross-functional teams with supervision
- Excellent communication skills, both written and oral
