MSD Biological Sciences Regulatory Affairs Specialist Recruitment
MSD Biological Sciences Regulatory Affairs Specialist Recruitment. Biological Sciences candidates apply for a Regulatory Affairs Specialist position that is available at MSD. Check out all of the details on the same below:
Name of the Position: Regulatory Affairs Specialist
No. of Openings: 02
Location: Vatika Towers, Gurgaon, India
Requisition ID: R130896
Job Description:
WHAT WILL YOU DO:
1. NEW PRODUCT REGISTRATION
- Develops, drives and finalizes new products approvals in India and for all products in neighbouring markets, in line with local regulatory requirements and business plans.
- Ensures submission in a timely manner and follow up to obtain earliest approvals for new products approvals in India and for neighbouring markets.
- During the assessment of the registration files, ensures adequate follow-up with regulatory agencies and addresses quickly agencies’ requests on quality clinical and non-clinical information.
- Coordinates actions effectively and proactively with HQ and local support groups and in order to support product launches in due time and avoid business loss.
2. MAINTENANCE OF EXISTING PRODUCTS
- Ensures timely submission and follow up of both labelling and quality-related variations to the marketing authorizations, in cooperation with the key stakeholders: Ex., worldwide product labelling, CMC, RAI, HQ and regional regulatory support team.
- Ensures timely submission and follow up of quality-related variations (CMC) to the marketing authorizations, in cooperation with the key stakeholders to the Health Agency laboratory.
- Manages renewal process in liaison with CMC, RAI, HQ and regional regulatory support team ensuring that renewal files are prepared, submitted and approved in due time.
- Efficient regulatory input for packaging and label components to ensure timely implementation of artwork efforts.
3. REGULATORY COMPLIANCE
- Responsible for implementing local regulatory procedures in a timely manner, in close synergy with HQ /regional groups.
- Trains appropriate personnel on regulatory procedures.
- Plans and tracks all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures
4. REGULATORY INTELLIGENCE
- Pro-actively shares intelligence on competitive products, generics, as well as on emerging regulations
- Responsible for supporting competitive intelligence
WHAT YOU MUST HAVE:
- Education – Bachelor degree in Biological Sciences – eg BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.
- Working knowledge of Indian regulatory mechanism
- Detail-oriented, meticulous and organized
- Basic IT knowledge
- Able to work within targeted timelines
- Good project management skills
- Self-motivated and strong commitment to achieving desired results and right first time
- Team player
Apply Online
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