Deskripsi Pekerjaan

DESKRIPSI PEKERJAAN

Executive recruitment company Monroe Consulting Group is recruiting on behalf of a leading multinational pharmaceutical companies. Our respected client is seeking a regulatory affairs professional, preferably with 8 years’ experience with a multinational pharmaceutical company, for the job of Regulatory Manager. The job is based in Jakarta, Indonesia. The winning candidate must have an extensive knowledge of government regulations and laws pertaining to the pharmaceutical industry and wider system of governance, as well as an extensive network of contacts and relationships within regulatory and relevant government institutions in Indonesia.  The successful applicant must be a professional of the highest integrity and moral character.
 
Key job responsibilities will include:
  • Ensure timely approvals of new product registration, variations and renewals
  • Develop and manage product registration strategies in line with company goals and maximizing the competitive advantages of company assets throughout the product lifecycle
  • Interface with the local management team in order to ensure regulatory strategies and processes are in line with local business strategy
  • Develop and maintain good and professional relationship with appropriate regulatory agencies to ensure smooth and efficient registration process
  • Manage labelling text and packaging components to ensure compliance with local registered details and corporate prescribing information, as well as maximizing the commercial values of the label.
  • Work with all appropriate local functions to develop and implement the best regulatory plans in order to achieve the local business targets
  • Interface with Area and International regulatory to ensure consistency and develop, improve and implement appropriate regulatory strategies: Request and attain all necessary documents for registration to International Regulatory Affairs; Arrange the registration dossier and provide all necessary documents to exported country as requested based on their requirements
  • Provide regulatory input into Clinical R&D plans and trials
  • Approve promotional and advertising material from regulatory standpoints as appropriate
  • Ensure local compliance with local, regional, and International/Corporate regulatory SOP’s
  • Monitor the regulatory environments and keep appropriate Local, Regional, and International regulatory functions aware of planned and actual changes
  • Monitor competitor regulatory activities and keep appropriate Local, Regional, and International regulatory functions informed of these
 
Job Requirements
 
  • Bachelor’s degree
  • Eight to 10 years of experience, preferably with multinational pharmaceutical company
  • Good managerial skills
  • Strong understanding of government regulations
  • Good relationship and extensive networking with MUI, BPOM, etc
  • Fluent in English (both written and spoken) is a must
  • Good communication skills
  • Integrity, honesty

Tentang Perusahaan

Address

Jl TB Simatupang, Kav. 36 Jakarta, Sovreign Plaza Building, 16th Floor

No. Telepon

62-21-29400040

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