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General Manager - Regulatory Affairs

12.00 to 15.00 Years   Mumbai City   17 Aug, 2021
Personnel Search Services Hiring For Glenmark
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryNot Mentioned
Functional AreaNot Mentioned
EmploymentTypeFull-time

Job Description

Job Title: GM - Regulatory AffairsLocation: MumbaiAbout Our Client:Our client is a leading global pharmaceutical company.Position Summary:Strategically plan and execute Regulatory plan for the region. Responsible for ensuring regional regulatory compliances, submissions, filings and approvals. Interface with Marketing/BD/Therapy leads/Project team/ Country teams for finalising regulatory filing plan. Guide country based regulatory resources on all regulatory related matters.Job Responsibilities:

  • Preparation and planning of an approvable New product filing grid and Re-registration grid for Asia Region and make necessary Presentations required for approval of the same.
  • To interface with Country Managers/Country RA/Consultants and Distributors for regulatory tracking and facilitating regulatory compliances
  • Grid Challenges to be addressed with BD and Marketing team on a monthly basis. Also to arrange for cross-functional meets towards resolving regulatory challenges
  • To manage the team and conduct reviews on regular intervals to track updates on various matters and assist in trouble shooting problems.
  • To update the Therapy Leads and GRA Team on changing requirements for Asia regions. To provide and maintain check lists on registration requirements for each country.
  • To archive and update various status reports for Asia and track approvals.
  • To co-ordinate with BD team for In-licensing projects for Asia.
  • To act as a SPOC for GRA and Project team with regards planning of sample batches for HO GRA. To attend project meetings and update status with regards artworks and licensing activities tracked.
  • Present the MIS/GRA MIS/Country MSRM scheduled on a Monthly basis.
Key Interfaces/ Interaction
  • External Interface: Distribution partners and their RA team, Ministry of Health officials in assigned markets, etc.
  • Internal Interface: Regulatory team based in India, Country based regulatory team, Country Managers, Marketing, Business Development, Projects team, etc.
Education:Masters Degree in Science / Pharmacy or equivalentExperience:At least 15 years of experience in Regulatory Affairs function in a pharmaceutical organisation with minimum 3 years experience in leading the regional regulatory team for Asian markets primarily Philippines, Malaysia, Australia, Myanmar, Cambodia, Vietnam, Thailand, Indonesia, Sri Lanka, etc.

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