Senior Regulatory Affairs Specialist

Senior Specialist Regulatory Affairs

Company Description

Good health can't wait. Patients need solutions and we find them.

As part of Dr Reddy's Laboratories, we are committed to improving the quality of life.

We contribute to better healthcare with innovative and cost-effective solutions - from prescription generics to innovative medical devices, biopharmaceuticals and over-the-counter medicines. In doing so, we always act in line with our sustainability goals.

We are looking for dynamic and empathetic individuals who share our vision and want to make a positive contribution to society.

Diversity, equality and inclusion are not just words for us, they are values we live by.

We believe that people with different abilities, united by a common purpose and shared values, can achieve great things.

Make an active contribution to people's health and well-being and make a real difference

Job Description

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 (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 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: B.Pharma/ M.Pharma/ 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.

Experience Level

Senior Level