Qualification : Should be M.Sc. (Organic Chemistry) or Equivalent
Competencies Required
- Chemistry Knowledge (A foundational understanding of chemistry and should be able to understand chemical properties and characteristics of the API)
- Communication Skills (Effective communication, both written and verbal)
- Listening and Teamwork
- Soft Skills (Adaptability, and interpersonal skills for effective interaction with colleagues, regulatory agencies, and other stakeholders)
Job Responsibilities
- Should be well versed with current Global Regulatory requirements for API submission.
- Should be having experience in identifying gaps during preparation and review of DMFs required for regulatory submissions.
- Should be having experience on handling electronic submissions.
- Should be having experience in conducting training sessions for plant personnel on current regulatory requirements
- Should be having experience in assessing change controls and defining regulatory strategies.
- Should be having experience in handling customer calls and troubleshoot the customer queries.
- Should be having experience in handling response to Regulatory deficiencies
- Should be having experience in participation of technology transfer meetings and collaborating with Cross function teams.
- Should be having experience in participation of Regulatory and Customer audits as a part of Regulatory Compliance.