REGULATORY MANAGER JOB (PHARMACEUTICALS) – MONROE CONSULTING GROUP

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Berikut informasi lowongan kerja REGULATORY MANAGER JOB (PHARMACEUTICALS) – MONROE CONSULTING GROUP yang dipublikasikan pada February 01, 2016 at 01:08PM. Silahkan anda simak untuk syarat, kualifikasi dan data pendukung yang diperlukan.

jobsDB Ref. JID200003001545223

Employer Ref. rhea01216

Monroe Consulting Group is a leading provider of senior human resource capital, specialising in servicing the worlds emerging economies within the Banking & Finance, Technology, Industrial and Consumer Goods Sectors

We commenced trading in Australia in 1998, initially expanding the brand within the Southeast Asian Region by opening offices in Indonesia, Malaysia, Singapore, the Philippines and Thailand. More recently we have opened offices Chile and Mexico.

Our brand is built around quality and professionalism. Our Recruitment Consultants are all highly trained and work unique specialist markets, which truly allows them to understand the needs of our clients and candidates both today and in the future. We have a host of internal systems that support our recruitment activities, many of which are widely utilised by a number of high-end recruitment organisations. However, it is only when used in conjunction with our own unique principles and customer driven values that our clients and applicants truly benefit.

As our goal is one of total customer satisfaction, our clients are able to tailor the service that will best meet their short-term and long-term human capital resourcing needs.

We are continually refining our Specialist Consultants’ skills and vertical areas to deliver customer-centric solutions. Our structure enables you to talk to someone with specialist market skills and Candidate knowledge. Team working and delivery mean that the network of resources available to you does not stop with one person

In essence, we advocate a proactive recruitment agenda, tailored to meet your needs.

Jakarta, Indonesia

Executive recruitment company Monroe Consulting Group Indonesia is recruiting on behalf of one of the world’s leading consumer goods companies. Our respected client is seeking a regulatory affairs professional, preferably with experience with a multinational pharmaceutical company, for the job of Regulatory Manager, to be based in Jakarta, Indonesia.

Key job responsibilities will include:

  • Ensure timely approvals of new product registration, variations & renewals
  • Develop and manage product registration strategies in line with company goals and maximizing the competitive advantages of company assets throughout the product lifecycl
  • 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, preferably from multinational pharmaceutical or consumer goods company
  • 8-10 years of experience
  • Strong attention to detail  
  • Strong understanding of government regulations
  • Good relationship and extensive networking with MUI, BPOM, etc
  • Fluent in English language (both written and spoken) is a must
  • Good communication skill
  • Good leadership skill

If you feel that you can meet the qualification and up to the challenge, please send your complete application (application letter, resume, expected salary, and any related supporting documents) and current color photograph at size 4 x 6 cm by clicking button below

Your application will go directly to
MONROE CONSULTING GROUP

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