Biological E - Head - Regulatory Affairs

Job Description

Biological E Ltd is a leading global vaccine & pharmaceutical company which provides affordable immunization and medicines across the world. It has current turnover of around 1000 Cr and having employee strength of around 2000, growing at around 36% CAGR. Our intellectual pool of experienced scientist are based out of India and France. BE has state of the art manufacturing sites in India (Hyderabad and Dehradun).

Position title : Head Regulatory Affairs

Location : Hyderabad/ Secunderabad

Academic Background and Experience:

PG in RA/ Pharma/Life sciences background with 15 years of experience

Purpose: To drive company's initiatives for the development of vaccines and biologics from regulatory perspective

Job responsibilities

- Preparation of ANDAs/ANDSs/Dossiers for Injectable drug products for submission to USFDA, and European agencies in accordance with current regulations.

- Collate and review all master documents and other documents required for preparation of ANDA/ANDS/Dossiers

- Co-ordination with internal as well as external counterparts, collate the data/documents and prepare the dossiers/applications in e-CTD and NeeS format

- Provide necessary regulatory inputs and clearances during the development to the product development team in discussion with Team Leader

- Support commercial launch Team by evaluation of changes proposed during commercialization/ validation phase in discussion with team leader

- Regulatory knowledge sharing with PDTs and to other RA team members and contribute towards continuous learning of self & other team members

- Review registration Dossier as per the regulatory requirements.

- Filling of registration dossier in specific regulated markets.

- Reviewing of documents like product manual, BMR, stability protocols, validation protocols and validation reports of process and analytical method of regulatory compliances.

- Liaison with various departments like Chemical/API R&D, Formulation R&D, Analytical R&D, QA, QC and various manufacturing units of Biological E Ltd

- Ensuring the quality of DMFs, addressal & closure of all incomplete comments on time, and sign off on open issues to ensure the support to the DMF referenced dossiers & Registrations.

- Communicate the new/updated/revised guidelines to the CFT on a need basis & ensure that the teams are aware about the latest updates

Operating Network

Internal: QA, DQA, cross functional authorities and R&D

External: Regulatory agencies and Functional authorities

Technical Requirements: :- Understanding of various ICH / EMEA / FDA /PMDA guidelines, Technical writing skill, Good training skills, Strong analysis and data mining skills

Key personal competencies: Good Communication skills, Networking skills, Time management and work prioritization ability, Confident, Self-starter (should be able to work independently with minimal supervision