Senior Manager Regulatory Affairs
MSD
Full time- 2+ years
- Not Disclosed
- Gurugram, India
- Post Date: Jan 27, 2023
- End Date: Mar 27, 2023
- 2+ years
- Not Disclosed
- Gurugram, India
- Post Date:Jan 27, 2023
- End Date: Mar 27, 2023
Skills:
- Quality control
- clinical research
- pharmacovigilance
Job Description:
Responsibilities
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Develops, drives and finalizes new products approvals in India and for all products in neighboring markets, in line with local regulatory requirements and business plans.
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Ensures submission in a timely manner and follow up to obtain earliest approvals for new products approvals in India and for neighboring markets.
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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.
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Coordinates actions effectively and proactively with HQ and local support groups and in order to support products launches in due time and avoid business loss.
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MAINTANENCE OF EXISTING PRODUCTS
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Ensures timely submission and follow up of both labeling and quality-related variations to the marketing authorizations, in cooperation with the key stakeholders Ex., worldwide product labeling, CMC, RAI, HQ and regional regulatory support team.
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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.
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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.
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Efficient regulatory input for packaging and label components to ensure timely implementation of artwork efforts.
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Responsible for implementing local regulatory procedures in a timely manner, in close synergy with HQ /regional groups.
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Trains appropriate personnel on regulatory procedures.
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Plans and tracks all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures
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Pro-actively shares intelligence on competitive products, generics, as well as on emerging regulations
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Responsible for supporting competitive intelligence
Qualification
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Education - Bachelor degree in Biological Sciences - eg BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.
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Working knowledge of Indian regulatory mechanism
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Detail oriented, meticulous and organized
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Basic IT knowledge
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Salary
Not Disclosed
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Role
Others
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Area of Practice
- Bio-chemistry
- Biotechnology
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Experience
2+ years
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