Regulatory Affairs (RA)- Executive
- BVR People
- 2 to 4 Yrs
- Bengaluru
- 2 years ago
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Job Description
Roles and Responsibilities
Dear Professionals,
Greetings!!!
We have Job opportunity for Regulatory Affairs - Executive - Formulations (Parenteral Dosage forms) at Hosur Near Bangalore
Position: Executive - Regulatory Affairs
Qualification M.Pharma (Regular only)
Experience - 2 To 4 Years
Responsibility:
1. Execute regulatory team activities as directed in making quality submissions and to achieve approval.
2. Maintain general knowledge of regulations and guidance for one or more product types (Injectables, API, etc.) for USA Market.
3. Collaborate with regulatory team to execute prototype assessment of under development projects
4. Coordinate with stake holders (RnD, Plant and suppliers) for sourcing of documents and review of executed documents received.
5. Collaborate with regulatory team to author/compile submission documents.
6. Collaborate with regulatory team to ensure all documentation is in compliance with eCTD standards. Should have experience in handling eCTD tools for compilation of submissions.
7. Preliminary review of the ANDA submissions.
8. Collaborate with regulatory team in handling deficiencies and post approval changes
9. Report and escalate incidents as situation demands
Carry out activities as assigned by the immediate supervisor from time to time, for which he is authorized to perform as per the SOP.Role Purpose:
This is Team lead position. The role holder is responsible for plan, review of all activities related to ANDA namely prototype assessment of development projects, review of executed documents, review and compilation of ANDA, handling of deficiencies, handling of post approval variations (annual reports and supplements). Co-ordination with cross functional teams for completion of the assigned activity. This role reports to supervisor and is team leader and an individual contributor.
Interested Candidates should forward their Updated Resume to ga******i@bv**c.com
Regards
K Ganapathi
Ph. No. 9600387***
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: General / Other Software
Functional Area: Not Applicable
Role/Responsibilies: Regulatory Affairs (RA)- Executive
Contact Details:
Company: BVR People ConsultingLocation(s): Bengaluru
BVR People
Company ProfileBVR People ConsultingBVR people consulting committed to help Organisations to realise and develop their full potential in order to compete in the present day globalised and technology driven business environment. BVRPC invigorates the key components of organizations - The People and...
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