Monroe Consulting Group
Regulatory Manager Job (Pharmaceuticals - Healthcare), Jakarta, Indonesia
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
- 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
|Industri||Manajemen Sumber Daya Mannusia / Konsultasi|
|Perusahaan||Monroe Consulting Group lihat lowongan lihat gaji lihat review lihat profil|
Monroe Consulting Group is a leading provider of senior human resource capital, specialising in servicing the worlds emerging markets in the Banking & Finance, Technology, Industrial and Consumer Goods Sectors.
We commenced trading in Australia in 1998 and have expanded across the South East Asian Region, opening offices in Indonesia, Malaysia, Singapore, the Philippines, Thailand, Chile and Mexico. In 2005 Empresaria Group PLC became the majority shareholder, giving us access to the resources of more than 80 offices around the globe.
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
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Monroe Consulting Group
- Masih Bekerja
- 26 Januari 2016
- Gaji & Benefit
- Work/Life Balance
- Senior Manajemen
- Nilai & Budaya
- Jenjang Karir
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