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Regulatory Affairs Head India

4.00 to 9.00 Years   Mumbai City   03 Feb, 2021
Merck Ltd
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSBU Head / CEO / Director,Sales / BD
EmploymentTypeFull-time

Job Description

A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.Your Role:Regulatory Affairs

  • To establish and maintain a system, organization and activities aimed for registration of the products of the organization in the India and Nepal; Sri Lanka, Bhutan; Bangladesh, Maldives; Pakistan and to keep a close check on the updates/ changes in the regulations that occur periodically.
Drug Safety
  • Detection, assessment, understanding and prevention/minimization of adverse effects or any other drug-related problem, in the global frame of a Safety Risk Management process.
Key Tasks & Responsibilities
  • Ensure on time submissions for Product registrations, Marketing approvals and import licences, including renewals and variations for all Global and Local products (Biotech & Drug products; Medical Devices and Cosmetics) for India and EFM & Pakistan
  • Ensure on time submissions of product registrations, variations and renewals for Nepal; Sri Lanka; Bangladesh; Bhutan; Maldives; Pakistan
  • Clinical trial dossier submission to Regulatory authority
  • Package Insert; updating for both Global and local products.
  • Artwork updating and creations for Biotech & Drug products; Medical Devices and Cosmetics
  • Follow-up with Regulatory authorities regularly.
  • Periodic screening of regulatory sites for updated information.
  • Writing and periodic review of Quality documents for Regulatory and Drug Safety functions.
  • Tracking of all applications made and approvals received from the Regulatory authorities.
  • Providing regulatory support to other internal departments.
  • Support in the new product launch process for India and EFM
  • Part of country leadership team; IBP and Risk Assessment team
  • Manage the team and their performance
  • Ensure RA budget compliance
  • Ensure Compliance to local laws, Company Compliance Policy ; Local SoP and be Audit Ready
Main Interfaces1. Internal
  • Marketing Department,
  • Quality Department,
  • Finance department
  • Business Development
  • Exports
  • SNO
  • Compliance Department
  • Medical Department,
  • Legal Department
  • Pharmacovigilance Department
2.External
  • Regulatory Agencies
  • Regulatory and Drug Safety Related Service Providers
  • Industry Associations
Who you are:Essentials
  • Minimal Educational Background: Graduate in Biology; Pharmacy
  • Minimun Experience: 7 Years in pharmaceutical industry
  • Skills:
  • Computer literacy
  • Good Presentation Skills
  • Knowledge of local regulatory and Drug Safety regulations and ability to comply with them.
  • Ability to work independently in a multifunctional environment
  • Total professional integrity
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!Curious Apply and find more information at https://jobs.vibrantm.com,

Keyskills :
product launchsafety regulationsnew product launchrisk managementdrug safetyrisk assessmentmedical devices

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