Merck Life Sciences Vacancy For MSc/PhD – Apply Online
Merck Life Sciences Vacancy For MSc/PhD – Apply Online. MSc/PhD Life Science/candidates apply online for Expert, Pharm Regulatory Advocacy position at Merck. Interested and eligible candidates check all the below:
Job Title: Expert, Pharm Regulatory Advocacy
Job Requisition ID: 208118
Location: Mumbai
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 an active role to build regulatory intelligence for Life Science. The 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 in 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.
- The secure flow of information from/to authorities, industry associations.
- Builds and keeps personal relationships with 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/PhD 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.
Apply Online
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