Job Summary
We are seeking a dynamic, motivated and experienced member in our Regulatory Affairs team. This position will be based at Delhi and the candidate should have at least 8-12 years of experience in Regulatory Affairs. Preferably, complete knowledge of Indian Regulatory Requirements with in-depth understanding of D&C Act, NDCTR, GMP, GCP, DMR, etc. This person will be responsible for handling (reviewing, submitting & follow up) applications pertaining to New Drug, Subsequent New Drugs, FDC, Biological (Vaccine, Biosimilar, CGT), GCT, Medical Device, BE for Export, Written confirmation, Cosmetics, etc. Experience will not be a barrier for the right candidate.
Roles & Responsibilities
- You will be responsible for liaising with Central Drugs Standard Control Organization (CDSCO), Zonal offices as well as State Drugs Offices for necessary Drugs approvals to support markets in India and emerging markets.
- You will be responsible to manage relationships with national regulators at CDSCO/Zonal/State levelਊnd other relevant regulatory agencies (IPC,NIB, NPPA, RCGM,etc).
- You will be responsible for reviewing & submitting of applications/portfolio assigned to you and also following up with the CDSCO/Zonal/State Regulators for the same.
- You will be responsible for providing necessary feedback to the Central Regulatory Affairs (RA) team based on day-to-day interactions with regulatory authorities.
- You will be responsible for Handling, reviewing, and approving artworks in compliance with regulatory requirements.
- You will be responsible for Tracking the validity and expiry of licenses and planning for the renewal of licenses and certificates, post approval commitments within regulatory timelines.
- You will be responsible for Supporting the Regulatory Affairs team with the necessary documentation for Drug registration and maintenance
- You will be responsible tonsure regulatory compliance for the approved products / products under filing and also in case of new regulations.
- You will be responsible for providing regulatory intelligence and keeping track of changing regulatory environment which may impact the organisation.
- You will be responsible for updating and maintaining a centralised Management Information System (MIS) database for all related activities on a daily basis.
- You will be responsible for maintaining the timelines for approvals, submissions, SEC meeting inclusions, etc.
- You will be responsible for developing and implementing regulatory strategies to support product development and lifecycle management.
- You will be responsible for collaborating with cross-functional teams to ensure regulatory compliance throughout the product development process.
- You will be responsible for preparing and reviewing regulatory submissions for clinical trials and marketing authorisations.
- You will be responsible for conducting regulatory risk assessments and developing mitigation strategies.
- You will be responsible for participating in regulatory inspections and audits, ensuring proper preparation and follow-up actions.
Completed university degree in pharmacy, biology or chemistry (or a comparable degree)
Interest in drug regulatory affairs (drug authorisation)
Very good written and spoken English, as communication within the company and with the authorities takes place in English
General IT affinity & good MS Office skills
Ability to work in a team, analytical thinking, flexibility, strong communication skills
