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Expert, Pharm Regulatory Advocacy

4.00 to 9.00 Years   Mumbai City   02 Apr, 2021
Merck Ltd
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaPharmacist / Medical Representative
EmploymentTypeFull-time

Job Description

A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.Your role:The candidate will be a key regulatory expert for the portfolio of Life Science, upstream, downstream and raw materials for the biopharmaceutical industry. The candidate should have an understanding of regulatory & quality for sterile drugs/biopharmaceuticals, including IND/NDA process, GMP and relevant regulations. In addition, the candidate must be well-versed in regulatory trends relevant to Life Science products.

  • Take active role to build regulatory intelligence for Life Science. Focused area includes Upstream, downstream process, raw materials management and new technology such as continuous manufacturing.
  • Drive thought leadership initiatives and build up relationship and advocacy with local authorities and industry associations in terms of business interests.
  • Safeguard LS strategic interests and objectives in arising guidance, standards and regulation.
  • Monitor and report on changes of relevant regulatory and compliance environment with impact with Life Science business. Analyze available regulatory and compliance information.
  • Increases the influence of important regulatory bodies and industry associations.
  • Secure flow of information from/to authorities, industry associations.
  • Builds and keeps personal relationships to local and national 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.
  • Builds processes for the flow of information and regulatory intelligence within India.
  • Definition of processes to implement upcoming regulatory needs and requirements.
  • Support regulatory & quality expertise and consultation for customer regulatory inquiries. Develop the strategy and provide guidance to customers on inspection/audit readiness and drug registration, include process validation, change control, etc.
  • Closely work with global regulatory surveillance & advocacy team and Life Science regulatory subject matter experts to link the local advocacy activities with global advocacy activities.
  • Monitor competitor approach regarding regulatory requirements.
Who you are:
  • Master/Ph.D. Life sciences or related science/engineering background with a strong emphasis in biologics/biopharmaceuticals.
  • 6years of relevant industry experience in quality & regulatory related to biopharmaceutical products.
  • Proven knowledge of cGMP, FDA, EMA, ISO 9001 standards, regulatory and compliance requirements, upstream and downstream process.
  • Knowledge/experience for regulations concerning complex biologics (i.e., monoclonal antibodies and recombinant proteins) expressed in mammalian cell culture.
  • Experience working in a global, matrix environment.
  • Able and willing to travel.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!Curious Apply and find more information at https://jobs.vibrantm.com,

Keyskills :
process validationmaterials managementmonoclonal antibodiesthought leadershipsubject matter expertsregulatory intelligencechange controliso 9001 standards raw materials

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