BS/BA degree in a Scientific Discipline; master's or higher preferred.
5+ years in the pharmaceutical industry, with at least 2 years of CMC regulatory experience.
Proficiency in preparing CMC regulatory documents including INDs, NDAs, and MAAs.
Solid understanding of FDA, EMA, and ICH guidelines.
Familiarity with drug development processes and post-approval regulations.
Demonstrated ability in developing CMC regulatory strategies.
Project management experience with a solution-oriented mindset.
Responsibilities
Develop the CMC regulatory strategy for small molecule submissions.
Prepare and review CMC submission documents and health authority briefing packages.
Evaluate CMC change controls globally with some supervision.
Manage CMC activities related to development and commercial projects.
Represent Regulatory CMC on various cross-functional teams.
Engage in global regulatory interactions with health authorities under supervision.
Facilitate discussions during document review meetings.
Benefits
Collaborative work environment across various functions.
Opportunity to influence global regulatory strategy.
Engagement with health authorities and regulatory affairs teams.
Professional development in an evolving regulatory landscape.
Full Job Description
Responsibilities:
Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, 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 (master's or higher preferred) with.
5+ years in the pharmaceutical industry, preferably with 2+ years CMC regulatory experience.
Experience with CMC regulatory documents (IND/CTAs, 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.
bility to plan/prioritize work of group members and guide/develop others.
bility to work on complex projects and within cross-functional teams with supervision.
Excellent communication skills, both written and oral.
