Job for M.Pharm/Ph.D as Regulatory Manager at Merck Limited

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Merck Limited was set up in India as the first Merck subsidiary in Asia in 1967.  The Company operates both its Pharmaceuticals and Chemicals businesses in the country.

Merck was also the first Merck Group Company to go public in the year 1981.  The Merck Group now holds 51% of the share capital in Merck Limited, while the remaining 49% is traded on the Bombay Stock Exchange Ltd. and National Stock Exchange of India Ltd.  Merck Specialities Pvt. Ltd., the wholly owned Indian subsidiary of Merck KGaA, was incorporated in 2005.

Post : Regulatory Manager APAC, Food & Beverage and Pharm Testing Regulatory Surveillance & Advocacy

Key Job Responsibilities:

  • Take active role to build regulatory intelligence in APAC. Focus on Food & Beverage and Pharmaceutical regulation, especially microbiological, physical and chemical testing for food and drug.
  • Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations.
  •  Safeguard Merck Life Science strategic interests and objectives in arising guidance, standards and regulation regarding food & drug testing.
  •  Monitor and report on changes of relevant regulatory and compliance environment with impact with Life Science business in testing area. Analyze available regulatory and compliance information.
  • Increases the influence of Merck in important APAC regulatory bodies and industry associations.
  • Actively participates and represents Merck Life Science in relevant industry associations.
  • Effective coordination of strategic activities of Life Science subject matter experts in regulatory bodies and industry associations.
  • Secure flow of information from/to authorities, industry associations and Merck Life Science.
  • Builds and keeps personal relationships to authorities.
  • Coordinates processes with internal functions for the commenting/drafting of regulatory/industry guidelines, regulations and standards.
  • Training for and support of internal stakeholders, external customers and relevant regulatory bodies.
  • Provide relevant training to educate Merck Life Science APAC commercials about new regulatory trends and developments that drive our value proposition.
  • Definition of processes to implement upcoming regulatory needs and requirements.
  • Support regulatory expertise and consultation for customer regulatory inquiries.
  • Proactively identify and communicate areas for operational and quality/regulatory improvement.
  • Provide decision support on a wide scope of operational and strategic matters impacting the achievement of the business's and function's objectives. Oversees APAC regulatory requirements for LS portfolio as a whole in conjunction with the Business and Operations.
  • Develops and documents standard processes, focus on implementing harmonized global processes.
  • Closely work with Life Science global regulatory surveillance & advocacy team and regulatory subject matter experts to link the local/regional advocacy activities with global advocacy activities.
  • Monitor competitor approach regarding regulatory requirements.

 

Education and Languages:
Master / Ph.D. in food & beverage, pharmaceutical, microbiology, chemical analysis, life sciences or related science background.
Fluent in English (verbal and written) is required.

Professional Skills and Experiences:

  • Minimum of 10 years of relevant industry experience, regulatory & government affairs, quality assurance/control experience related to food & beverage, pharmaceuticals and microbiological & chemical analysis.
  • Knowledgeable of food & drug regulations and regulatory landscape of other important country/regions (eg. India, EU, US)
  • Knowledge/experience of food regulations/standard, Pharmacopeia regarding microbiological testing, physical & chemical testing, pesticides/heavy metals residual testing, ISO standards, other regulatory and compliance requirements.
  • Experience of working in industry associations, standard organization, testing institutes and government bodies for industry guidelines/standard/regulation drafting, revision, comment and discussion of above mentioned area.
  • Experience working in a global, matrix environment.

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