We are seeking an experienced
Regulatory CMC Manager to support global Chemistry, Manufacturing, and Controls (CMC) regulatory activities for marketed pharmaceutical products. This role is ideal for professionals with expertise in international regulatory submissions, lifecycle management, and cross-functional collaboration within the pharmaceutical industry.
Key Responsibilities
- Execute Regulatory CMC lifecycle management (LCM) strategies for marketed products.
- Plan, prepare, and coordinate international CMC regulatory submissions.
- Develop content plans and ensure alignment across cross-functional teams.
- Review CMC sections of regulatory submissions and agency responses.
- Collaborate with global regulatory teams to support CMC strategies and submissions.
- Serve as the Regulatory CMC representative for assigned products and projects.
- Provide regulatory guidance on change controls, deviations, GMP investigations, and product compliance activities.
- Support interactions with global regulatory agencies and ensure compliance with applicable regulations.
Required Qualifications
- Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or another related Life Sciences discipline.
- Minimum
5+ years of experience in Regulatory CMC within the pharmaceutical or biotechnology industry.
- Strong knowledge of
FDA, EMA, ICH
, and international regulatory requirements.
- Experience preparing and reviewing CMC regulatory submissions.
- Excellent communication, planning, problem-solving, and stakeholder management skills.
- Ability to work effectively with cross-functional global teams.
Preferred Qualifications
L&T Technology Services