Manager/Senior Manager - Regulatory Affairs - Pharma

We have an urgent opening for one of the leading Pharmaceutical company for the profile of "Manager/Sr. Manager Regulatory Affairs" in Punjab location.

Key areas of Accountability/Responsibility

1. Running Business -To ansa Site

- Global Registrations

- Technical Dossier and Documents preparations and updates

2. Running Business-for AP is made in other Bus -Registration in India

- Registration in India.

3. NBD-APis made outside AMEA (e.g. BU-China and others)-Cefaclor, Cefadroxil and other New additions (as and when applicable

Portfolio products -Current & New Additions (as and when applicable)

- Registration in India

4. GMP Applications and Certifications -Toansa and other sites in India

- Preparation, Submission of application and follow up on queries with Drug Regulatory authorities till issuance of certificate.

5.Submission and Liasion with Drug Controller General India (DCGI), State Drug Control Authorities and Zonal Drug Control Authorities.

- DCGI Central and Zonal Drug Control office (North)

- Import Registration (Form-41)

Knowledge and educational level

1.Have a broad and in-depth knowledge and experience on regulatory registration processes and guidelines of various national and international agencies for Active pharmaceutical ingredients.

2.Experience and knowledge on registration requirements and processes of finished products (various dosage forms).

3.Dealt with many agencies directly and indirectly including USFDA / EDQM / EU / KFDA / PMDA / COFEPRIS / ANVISA for obtaining approvals.

4.GMP and Quality control procedures.

5.Knowledge on Chemical Production / manufacturing and controls to be followed

Education

Masters in Chemistry

9.Required level of experiences

Minimum12 - 20 years

Relevant experience in API / Formulation industry.

Ritu Agarwal
Senior HR Consultant