Senior Manager Regulatory Affairs Pharmacovigilance - Mumbai 19011
Senior Manager Regulatory Affairs Pharmacovigilance - Mumbai 19011
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Job Description
The Position
Coordinate for PR completion to obtain dossier. Preparing quality documents in timely and compliant manner to ensure zero rejections. Follow up with Regulators for speedy approval in India. To liaison with the Regulatory Authorities in order to ensure smooth process of drug registration. To adapt and align SOPs and process flows to the new policies and regulations. Ensure ontime testing of products at approved test labs in India and BNS. Ensure ontime filing of Form 3 and 5 for NLEM and pricing.
Tasks & Responsibilities
- Prepare registration plan as per LTF or Global strategic products registration.
- Register PV complaints in internal system tools as per SOP.
- Submit PSURs periodically as per local regulations.
- Obtain dossiers and prepare documents as per checklist.
- Follow up with regulators and consultant for speedy approval.
- Ensuring all product registrations renewals artworks PV complaints meets local regulations.
- The job needs to fulfill regulations as laid down by CDSCO Government of India DGDA (Bangladesh)and Sri Lankan authorities.
- PV complaints needs to follow SOP and timely closure and submission to local regulators. PSUR submissions to be completed on time as per regulatory requirements.
- Regulatory affairs need to work with various internal teams like Global RA Regional RA Marketing Technical Manufacturing Quality Finance and Purchase.
- Register new and new indications in line with the business strategy.
- Ensure regulatory compliance of packaging.
- Responsible for creating and updating labelling of products.
- To adapt and align our SOPs and process flows to the new policies and regulations released by health authorities.
- Testing at IVRL / CDTL / or any government laboratory.
Requirements
- Education: Graduate Degree (preferably in Veterinary Sciences/Pharmacy); any post graduate degree (masters in veterinary sciences /pharmacy preferred)
- Familiarity with & Cosmetics Act & Rules with all relevant schedules
- Familiarity with guidelines for New Drug Approvals Site Registrations
- Good Understanding of India Bangladesh Sri Lanka and Nepal guidelines for Industry
- The candidate should have more than 7 years of Regulatory and Pharmacovigilance experience.
- The candidate should possess skills related SUGAM online applications.
- Good communication skills with fluency in English and Hindi
- Position will work at Mumbai.
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Required Experience:
Senior Manager
Employment Type
Full-Time
