Job Title: Senior Executive - Regulatory Affaris
Purpose of Job
The purpose of the job is to take the responsibility of Dossier requests received from internal business partners.
Skill Required
- Experience of handling registrations of biosimilars in regulated and semi regulated markets.
- Experience of drafting dossier sections
- Experience of drafting query responses
- Experience of interactions and co-ordination with CFTs
- Strong communication skills
- Experience of handling RA tools
Roles and Responsibilites
Summary of Job Functions:
Responsible for preparation of regulatory submissions (regulated and semi regulated markets)
Key Responsibilities:
- Responsible for authoring IMPD and MAA by collating all the documents for registration of biosimilar products in regulated market – EU/US/ROW regions
- Preparation of scientific advice and briefing book documents for biosimilars
- Preparation of responses to queries received from various regulatory agencies
- To work within regulatory teams for effective preparation of CMC documents for regulated and semi regulated markets.
- Updating and maintaining the regulatory trackers with the required details
- Provide necessary regulatory assessment for change controls
Qualification Required
M.Pharm/B.Pharm from reputed university
Biological experience is added advantage/preferable
Competencies
Relevant skills / Industry experience
Relevant professional / Educational background
Any other requirements (If any)
Compensation / Reward
Biotech, Ahmedabad, GJ, IN, 382213