Regulatory Affairs (RA)- Executive -Formulations (Parenteral) in Hosur

From 2 to 4 year(s) of experience
₹ Not Disclosed by Recruiter

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 ganapathi@bvrpc.com

Regards


K Ganapathi

Ph. No. 9600387468


Role:Regulatory Affairs Compliance

Salary: Not Disclosed by Recruiter

Industry:Pharmaceutical & Life Sciences

Functional AreaLegal & Regulatory

Role CategoryCorporate Affairs

Employment Type:Full Time, Permanent

Education

PG:M.Pharma in Any Specialization

Company Profile

BVR People Consulting

BVR 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 ‘The Processes’. It is our endeavour to facilitate this process of ‘Rejuvenating Organisations’ through a variety of customised, innovative and practical solutions that bring about positive attitudinal shifts, while driving organisations to re-assess their true potential. These solutions are designed based on a thorough ‘Diagnosis’ and ‘Need Audit’ of the organisation. We work with our clients as partners and a team. Our solutions are tailored for each client's unique needs and business context, and are designed to ensure that clients get the best return on their investment.
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Recruiter Name:K Ganapathi

Contact Company:BVR People Consulting

Telephone:9600387468

Email:ganapathi@bvrpc.com

Website:http://careers.bvrpc.com