Regulatory Affairs Specialist
- Samrat Job Point
- 6 to 11 Yrs
- Multi-City, India
- 3 years ago
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Job Description
Regulatory affairs specialist job description:
The mission of the Regulatory Affairs Specialist (RAS) is to prepare and file demands for regulatory approval of the products of ones company. Biotechnology companies, which have lesser means than large pharmaceutical companies, prioritize experienced candidates or else turn to consultants. The Regulatory Affairs Specialist in biotechnology thus plays a very strategic role and is involved in all stages of the process, whereas its counterpart in the pharmaceutical industry has more delineated responsibilities, involving more administrative tasks.
The Regulatory Affairs Specialist stays with the same company for an average of 10 to 15 years; the rate of turnaround is therefore low. Networking is very much encouraged, through joining various associations to participate in conferences and exhibitions, and also to access current literature. Presently, there is a strong demand for Regulatory Affairs Specialists in medical device companies.
Main duties of the regulatory affairs specialist:
Prepare, coordinate and supervise regulatory submissions
Review product conformance and assure compliance
Implement different strategies in order to meet evolving regulatory initiatives
Register products according to provincial guidelines and regulations of third party suppliers
Keep current with regulations
Participate in conferences and interdepartmental meetings
Education to become a regulatory affairs specialist:
It is recommended to have a university degree in the sciences (Bachelors, Masters, PhD), whether it be in biology, chemistry, toxicology, pharmacology, etc.
Skills:
Expertise in laboratory analysis, manufacturing procedures and clinical testing
At minimum, thorough understanding of Canadian regulations (familiarity with American and European regulations an asset)
Broad knowledge of mathematics, physics, chemistry and biology
Strong computer skills
Must be bilingual
Personal characteristics
Strategic and innovative spirit
Attention to detail
Maturity, autonomy and sound judgment
Organizational skills
Interpersonal skills
Writing skills
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: Pharmacist / Medical Representative
Functional Area: Not Applicable
Role/Responsibilies: Regulatory Affairs Specialist
Contact Details:
Company: Samrat Job PointLocation(s): Multi-City, India
Samrat Job Point
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