Assistant Manager

Qualification : Should be M.Sc. (Organic Chemistry) or Equivalent

Looking for core regulatory experience candidates

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.