Regulatory Affairs Specialist at IQVIA, BSc Life Science candidates can apply!
A global leader in advanced analytics, technology solutions, and contract research services to the life sciences industry, is seeking a Regulatory Affairs Specialist to join its team in Bengaluru. This is an exciting opportunity for professionals with a life sciences background to contribute to the development and approval of innovative healthcare solutions that improve patient outcomes globally.
Location: Bengaluru, India
Employment Type: Full-time
Job Code: R1478378
Job Description
Job Overview: Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision.
Essential Functions of a Regulatory Affairs Specialist- IQVIA
- Acts as a Regulatory Team Leader on more complex projects, which may include technical writing.
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate.
- Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments.
- Acts as an SME/ expert in regulatory knowledge in chemistry, manufacturing, and controls, as well as lifecycle maintenance, marketing authorization transfers, labeling, and publishing as applicable.
Qualifications
- Bachelor’s Degree in Life Science or related discipline Req. Or Master’s Degree in Lifescience or related discipline Req.
- At least 3-4 years of relevant experience.
- Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws, and related guidelines, as appropriate.
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