Regulatory Affairs Professional with Market Authorization Expertise

1 week ago

Mumbai, Maharashtra, India Astellas Pharma Full time
About the Role

We are seeking an experienced Regulatory Affairs Manager to join our team at Astellas Pharma India, based in Mumbai. This is a fantastic opportunity for someone who has a strong background in regulatory affairs and a passion for ensuring compliance with Indian pharmaceutical regulations.

Key Responsibilities
  • Market Authorization Planning: Collaborate with internal stakeholders to plan and prepare market authorization submissions for new products in India, ensuring timely submission and approval.
  • Regulatory Dossier Preparation: Prepare and compile comprehensive regulatory dossiers for market authorization, adhering to relevant regulations and guidelines.
  • Post-Approval Changes: Assess and submit post-approval changes/variations to the regulatory authority, ensuring continued compliance.
  • Global RA Coordination: Coordinate with the global RA team to assess and implement new regulations and compliances, supporting RA projects as needed.
  • Registration Maintenance: Maintain product registrations and licenses through timely planning and submission of renewals, ensuring business continuity.
  • Regulatory Support: Provide regulatory consultation and support to internal stakeholders, including Medical Affairs, Marketing, Supply Chain, Commercial & Sales teams.
  • RA Systems Management: Manage the implementation, utilization, and compliance to RA systems, including Veeva, EAGLE, GRACE, CCTA, and BLUE.
Product Safety Information Management
  • PV Mailbox Monitoring: Monitor the PV mailbox, 24/7 PV telephone, and other sources of product safety information, capturing adverse events and other safety data.
  • Safety Information Processing: Process safety information received from all sources, complying with required timelines, quality guidelines, and standards.
  • PV Case Tracking: Use PV Case Tracking System, PV Register/LSIT/LSMV to capture Product Safety Information accurately.
  • Local Literature Searches: Conduct local literature searches for Product Safety Information according to relevant procedures, if applicable.
  • Follow-up Actions: Conduct and document follow-up actions on Product Safety Information as required per relevant procedures.
Requirements
  • Education: University graduate and master majored in life science, medicine, or pharmaceuticals.
  • Experience: Minimum of 5-8 years of working experience in the pharmaceutical industry, with at least 5 years of experience in regulatory affairs specifically in registration of new drugs.
  • Skills: Good knowledge of the Indian regulatory environment, Drugs and Cosmetics Act & Rules, India, and regulations on new drug registration and clinical trials.
  • Language: Good English language skills for communication with global colleagues.
Estimated Salary

Rupees 30,00,000 - Rupees 50,00,000 per annum (based on location and experience), depending on qualifications and performance.

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