Work as Senior Regulatory Affairs Associate at PAREXEL
PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries. They have helped over 800 clients to develop and launch some of the most important drugs and devices of our time-helping people live better and healthier lives everywhere in the world.
Post : Senior Regulatory Affairs Associate
1. To support post approval Labelling variation submissions.
2. Experts in core labeling documents example Core Patient Information Leaflet, including labelling history documents.
3. Support operational and compliance activities.
4. To support all regulatory activities based on project requirement.
1) A post graduate degree in a relevant educational field - life science, pharmacy, others.
2) 5 to 7 years experience with Pharmaceutical industry or CRO with general understanding of Regulatory Affairs, post approval labelling variation submission with Health Authority.
3) Knowledge of SmPC, SPL, USPI, PM, Artwork updation and review system
3) Good communication skills
4) Willing to work preferably in EU shift or as per project requirement
Location: Bengaluru, Karnataka, India
Education: M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory Affairs
End Date: 20th May, 2019
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