Head - Research & Development - Formulation - Startup

Head - Research & Development

Job Overview

To lead and manage the entire gamut of Research & development activities including Formulation, Analytical development scale-up for registration, and oversee the commercial launch of approved marketing authorization from different regulatory agencies.

Key Responsibilities:

- Should have been in leadership role of handing cross-functional team of Formulation Development (FD), Analytical Development (AD), Technology Transfer (TT), and Regulatory Affairs (RA) for the development and undertaking product development.

- Candidate should be well-versed with the regulatory guidance related to generic product development and BE-studies.

- Sound knowledge of management of all research and development activities, preparation of documents BMR, BPR, production manual, validation protocol & reports, stability protocol & cleaning validation protocol.

- Pre-formulation studies. Design, Stability & Pilot plant batches in R&D

- Ensure that creative work is undertaken on a systematic basis in order to increase the stock of knowledge, and the use of this knowledge to devise new products

- Overall planning, supervision and co-ordination of day to day operations of R&D Directing and guiding the scientists in planning and execution of R&D projects

- Assisting in preparation and monitoring annual budgets for R&D products and projects.

- Support the preparation of all types of regulatory documentation associated with approval.

- Support the preparation of marketing dossiers and product dossiers for Semi-regulated Markets, Variations and Renewals.

- Assist in commercial launch of products from approved licenses from different regulatory agencies.

- Should have the knowledge and exposure of submitting budget proposals for the various projects to the Management.

Technical Competencies:

- Sound knowledge about the Solid oral product development tablets, capsules, immediate release, delayed release, control release concepts.

- Candidate should have thorough knowledge of product development for highly regulated (especially history of filing for EU market).

- Well versed with "National, Mutual Recognition, De-centralized, and Centralized" registration procedures.

Work Experience : Minimum 20-25 years

Educational Qualification : M Pharma /PhD