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22 October 2019
Job ID: BK-148958
Regulatory Specialist

Academic Background and Experience:

  • Registered Pharmacist, Graduation or Post Graduation from reputed institute or university with a minimum of 5 to 6 years of relevant experience in regulatory affairs function.
  • Work experience within complex generics, especially oncology would be desirable
  • Candidates must have experience of working with Thai FDA

Job responsibilities:

  • Keeping up to date with drug regulations, guidelines, including proposed and final rules. Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
  • Preparing and sharing the regulatory filing & approval strategies and implementation plans for new products. Provide regulatory guidance to departments or development project teams.
  • The complete ownership of regulatory submissions and approval process including but not limited to regulatory consultant selection, on-boarding, supervising in preparing, reviewing submission and obtaining product registration, including coordination with regulatory consulting firms. Support query / deficiencies response preparation and submission, File and Maintain product packaging inserts and labels (PIL) and Summary of Product Characteristics (SPCs)
  • Guide DRL RA and local consultants in the submission and approval of product approval changes including PIL and SPCs.  Assist in Product Life Cycle Management (regulatory trackers, variations filings, re-registration filings etc.)
  • Manage activities such as regulatory audits as may be required.
  • Network & Build relationships with regulatory professionals and external key opinion leaders (KOLs). Facilitate discussions on how to expedite our regulatory filings with the help of external consultants and KOLs.  Coordinate/Interact with respective network contacts internal to Generics and Biologics division.
  • Interact with supporting Intellectual Property counsel to be informed on trademark and patent filings with respect to our generic and bio-similar products and competitive landscape.
  • Target of 9 successful dossier submissions.
  • Preparing, filing and handling end-to-end regulatory activities for at least 3 product dossiers by without using the regulatory consultants.
  • Securing at least 3 product approvals including bio similar and small molecules.
  • Coordinating and arranging scientific advisory meetings with Thai FDA on need basis.

Key personal competencies:

  • Ability to work with cross-functional teams across different parts of the world with high degree of collaborations.
  • Ability to manage and motivate team
  • Values, Integrity and Ethical conduct.
  • Ability to connect the commercial aspects of business
  • Strong internal and external networking skills
  • Demonstrate logical and persuasive skills
  • Good knowledge and command over both English and local language

 Operating network:

Internal: Country Head, Group Country Head, Regulatory Head Emerging Markets, Business Manager, Portfolio Team

External: Regulators, External Regulatory Consultant, KOLs in the Industry

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Job Details:

Benefits:
  • Five-day work week
  • Performance bonus
  • Transportation allowance
  • Medical insurance

Dr.Reddy’s Laboratories (Thailand) Ltd.
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