Senior Specialist Regulatory Affairs

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 level and other relevant regulatory agencies (IPCNIB NPPA RCGMetc).
• 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 to ensure 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.

Qualifications :

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

Additional Information :

Educational qualification: Life Science Graduate or PG

Minimum work experience: 6 to 20 years preferable 12

Skills & attributes:

Technical Skills

• Understanding of Good Manufacturing Practice/Quality Systems D&C Act NDCTR etc.
• Understanding of product development manufacturing processes Intellectual Property and quality.
• Knowledge of Indian Regulatory requirements.
• Proficiency in regulatory information management systems and databases.
• Familiarity with international regulatory guidelines (e.g. ICH WHO).
• Experience in preparing and reviewing regulatory submissions for various product types.
• Knowledge of pharmacovigilance and post-marketing surveillance requirements.

Behavioural Skills

• Excellent communication and interpersonal skills.
• Efficient team player and a good collaborator.
• Good influencing skills.
• Strong analytical and problem-solving abilities.
• Attention to detail and ability to manage multiple projects simultaneously.
• Adaptability to changing regulatory landscapes and organisational priorities.

Additional Requirements

• Proficiency in Microsoft Office suite and regulatory-specific software.
• Willingness to travel for regulatory meetings and inspections.

Remote Work :

No

Employment Type :

Full-time