Bachelor's Degree in life sciences, engineering, or other technical discipline.
3-5+ years in the pharmaceutical industry, with 2+ years in CMC regulatory experience.
Experience with key CMC regulatory documents (IND/CTAs, NDAs, MAAs, etc.).
Familiarity with FDA, EMA, and ICH guidelines and CMC regulations.
Knowledge of drug development processes and post-approval requirements.
Ability to develop CMC regulatory strategies and manage projects.
Proven problem-solving skills with a solution-oriented approach.
Experience in planning and prioritizing group work, with mentoring capabilities.
Responsibilities
Develop CMC regulatory strategies for small molecules.
Prepare and review regulatory submission documents and responses to health authorities.
Manage global regulatory evaluations of CMC change controls under supervision.
Handle CMC activities for developmental or commercial compounds with oversight.
Represent Regulatory CMC on cross-functional teams and during regulatory discussions.
Participate in global interactions with health authorities, with guidance.
Facilitate document review meetings and discussions to ensure clarity and alignment.
Stay updated on regulatory environment and procedures.
Benefits
Collaborative work environment with cross-functional teams.
Opportunities for professional development and mentorship.
Access to resources for continuing education and skill enhancement.
Engagement with global health authorities in a dynamic 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:
Bachelor's Degree in life sciences or engineering, or other technical discipline.
3-5+ 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 the 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.
