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Regulatory Affairs(US Markets) For leading pharma company in Hyderabad

Hiring for Leading Pharma company

2 - 6 Years

Hyderabad

Not Disclosed by Recruiter

Walkin Interview on 14th September from 9 AM

Interview Date: Saturday,14th Sep 2019 Interview place: Hyderabad Interview Address: Soon I will share you. Contact person: Mr.Zabi Moghal Mobile: 7676936384 Email: zabi@bvrpc.com

Applicants need to go to the venue mentioned or call on the number provided below
Posted: 9 days ago

Job Description

Job Title: Regulatory Affairs (US Markets)
Company: Leading Pharma company in Hyderabad Location
Designation: Executive
No. of Positions: 5
Division: Formulation Injectables
Department: Regulatory Affairs
Job Location: Hyderabad Location
Qualification: B.Pharma / M.Pharma
Years of Experience: 2 to 4 Years
Salary Range: 6 LPA (Max)

Contact person: Mr.Zabi Moghal
Mobile: 7676936384
Email: zabi@bvrpc.com


Roles & Responsibilities:

  1. Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality and regulatory standards in dossiers.
  2. Review and submission of Annual Reports (ANDAs/ NDAs).
  3. Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality and regulatory standards in response.
  4. Evaluation and good interpretation of Post approval changes. Submission of supplements like CBE, CBE-30 and Prior Approval Supplement (PAS).
  5. Knowledge of Ectd, Module 2 and 3.
Strategic:
  1. Formulate US regulatory filing strategy for new projects.
  2. Good interpersonal skill for ICH & FDA guideline.
  3. SOP identification, preparation, review & implementation.
People Oriented :
  • Working in close partnership with other department like: FRD/ FRAD/ DMF holders/ QA etc.,


Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology
Role Category: Drug Regulatory Affairs/Documentation
Role: Regulatory Affairs Manager
Employment Type: Full Time, Permanent

Desired Candidate Profile


Education:UG -B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy

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.
View Contact Details+
Contact Details

Recruiter Name:Mr Moghal Zabi

Contact Company:BVR People Consulting

Telephone:7676936384

Website:http://careers.bvrpc.com