Opportunity as Associate License Management @Merck Limited

Website Merck Limited

Merck Limited was indeed established in India as the first Merck subsidiary in Asia in 1967. The company operates in both the Pharmaceuticals and Chemicals sectors in India. Merck Limited was also the first Merck Group Company to go public in 1981.In September 2021, the Merck Group holds 51% of the share capital in Merck Limited, while the remaining 49% is traded on the Bombay Stock Exchange Ltd.

Job Title: Associate License Management

Experience: Minimum 4 years in Pharma environment, Competent authority, or Academia/R&D (with at least 3 years in Regulatory Affairs)

Qualification: Degree in a Life Science, Medical, PharmD, or related discipline (minimum MSc or equivalent, higher degree preferable)

Location: Bangalore

Industry: Pharma / Healthcare / Clinical research

End Date: 30th July, 2023

Job Description Summary: The Specialist Licence Management is responsible for preparing dossiers and executing actions that support license security and product compliance. This includes meeting the company’s and health authorities’ requirements. The role involves collaborating with stakeholders from various functions within or outside Global Regulatory Affairs to develop and implement license management strategies. The position operates in a matrix organization and requires working on complex tasks, proposing solutions, and developing strategies.

Candidate Profile:

  • Minimum 4 years of overall work experience in the Pharma industry, Competent authority, or Academia/R&D (with at least 3 years in Regulatory Affairs).
  • Degree in a Life Science, Medical, PharmD, or related discipline (minimum MSc or equivalent, higher degree preferable).
  • Ability to contribute to and review regulatory documentation, develop regulatory strategies and dossiers.
  • Experience in preparation and management of regulatory documentation, including international submissions or large variations.
  • Familiarity with life-cycle management activities in multiple regions (e.g., Europe, USA, International).
  • Solid experience in Regulatory Affairs and understanding of global regulatory environment, including registration procedures and LCM strategies.
  • Knowledge of country-specific and international regulatory guidelines, policies, and regulations.
  • Strong project management, documentation, and communication skills.
  • Ability to assess and mitigate risks, provide regulatory expertise in project planning and execution.
  • Experience with Veeva Vault Registration module and EDMS RA applications (contributor level).
  • Excellent written and spoken communication skills in English.

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