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| Job Location | Kolkata |
| Education | Not Mentioned |
| Salary | Rs 6 - 14 Lakh/Yr |
| Industry | Pharma / Biotech |
| Functional Area | Pharmacist / Medical Representative,Bio Tech / R&D / Scientist |
| EmploymentType | Full-time |
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 submissionsReview product conformance and assure complianceImplement different strategies in order to meet evolving regulatory initiativesRegister products according to provincial guidelines and regulations of third party suppliersKeep current with regulationsParticipate in conferences and interdepartmental meetingsEducation 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 testingAt minimum, thorough understanding of Canadian regulations (familiarity with American and European regulations an asset)Broad knowledge of mathematics, physics, chemistry and biologyStrong computer skillsMust be bilingualPersonal characteristics Strategic and innovative spiritAttention to detailMaturity, autonomy and sound judgmentOrganizational skillsInterpersonal skillsWriting skills
Keyskills :
accesscontinuous improvement facilitationfunctionaldemandbiologyregulatory affairsdeliverypharmaceutical industryjoiningstrategyanalysisdocumentationphysicssoundpharmaceutical companiesturndatabase administrationfdamedical