Post: Assoc. Scientist, Regulatory Affairs-CMC
Job Description
Regulatory Responsibilities:
- Global Regulatory Strategy: Provide input to global product and project regulatory strategies by assessing CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation to assess acceptability and identify potential risks.
- Execution of Regulatory Strategies: Lead the development, authoring, and review of CMC submission components and documentation to support post-approval supplements/variations, annual reports, registration renewals, and responses to health authority questions. Ensure compliance with established business processes and systems.
- Collaboration and Liaison: Liaise with global CMC, Our Manufacturing Division, and external partners to ensure compliant execution of change management activities while maintaining a focus on regulatory conformance.
- Risk Assessment and Mitigation: Assess and communicate potential regulatory risks, proposing mitigation strategies to ensure regulatory milestones are achieved across the product lifecycle.
- Issue Identification and Communication: Identify and communicate potential regulatory issues to GRACS CMC management as necessary.
Technical Skills:
- Scientific Review: Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale, ensuring clarity in presentation and adequate support by data.
- Communication: Demonstrated oral and written communication skills, with the ability to communicate issues succinctly and logically. Strong listening skills are essential.
- Understanding of Related Fields: Demonstrated understanding of related fields such as pharmaceutical manufacturing, analytical testing, and quality assurance.
- Computer Proficiency: Proficient computer skills, with demonstrated ability to operate in electronic document-based GMP systems.
Candidate Profile
- Education: Bachelor of Science, Engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
- Experience: 0 – 3 years of industry experience in the pharmaceutical sector.
- Problem-Solving Skills: Demonstrated ability to generate innovative solutions to problems and effectively communicate with key stakeholders.
- Adaptability: Demonstrated flexibility in responding to changing priorities or unexpected events.
- Time Management: Capability to handle multiple priorities and balance work to achieve business goals.
- Interpersonal Skills: Demonstrated effective leadership, communication, and interpersonal skills.
Additional Information
- Experience: 0 – 3 years
- Qualification: B.Pharm, B.Sc
- Location: Mumbai, Maharashtra; Pune, Maharashtra; Hyderabad, Telangana
- Industry Type: Pharma/ Healthcare/ Clinical Research
- Functional Area: Regulatory Affairs – CMC
- End Date: 20th April 2024
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