Regulatory Consultant (CMC Module 3)
New
IndiaFull-TimeSenior
Salary not disclosed
Apply NowOpens the employer's application page
Job Details
- Experience
- 6–12 years
- Required Skills
- Quality Assurance
Requirements
- 6–12 years of experience in Regulatory Affairs with strong expertise in CMC Module 3 authoring and review.
- Hands-on experience in post-approval lifecycle management, including variations and global submissions.
- Strong knowledge of EU regulatory requirements, with exposure to US and ROW regulatory frameworks.
- Experience in API and Drug Product (DP) regulatory submissions and lifecycle activities.
- Familiarity with eCTD submission standards and regulatory documentation tools.
- Strong analytical, problem-solving, and documentation skills with attention to regulatory detail.
- Excellent communication and stakeholder management abilities across global, cross-functional teams.
- Ability to work independently, manage multiple priorities, and deliver under tight regulatory timelines.
- Master’s degree (M.Pharm / M.Sc. or equivalent) in Life Sciences or related field.
Responsibilities
- Author and review CMC Module 3 documentation for post-approval submissions and lifecycle management activities across global markets.
- Prepare and manage regulatory variation submissions including EU (Type IA, IB, II), US (CBE, PAS), and ROW regulatory requirements.
- Support site transfer activities by coordinating documentation, regulatory strategy inputs, and cross-functional alignment.
- Collaborate with manufacturing, QA, QC, and supply chain teams to ensure accuracy, completeness, and compliance of regulatory data.
- Track, manage, and deliver assigned regulatory activities within defined timelines and regulatory expectations.
- Respond to health authority queries and deficiency letters, ensuring timely, accurate, and compliant resolutions.
- Participate in cross-functional and client meetings as a regulatory subject matter expert and provide technical guidance to internal teams.
- Ensure adherence to regulatory standards, project scope, and submission timelines while maintaining high-quality deliverables.
View Full Description & ApplyYou'll be redirected to the employer's site
