Regulatory Affairs Manager
Regulatory Affairs Manager
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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 812 years of experience in Regulatory Affairs. Preferably complete knowledge of Indian Regulatory Requirements with indepth 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 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 Standard Control Organization (CDSCO) Zonal offices as well as State Offices for necessary 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 daytoday 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 crossfunctional 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 followup actions.
Qualifications :
Educational qualification: Life Science Graduate or PG
Minimum work experience: 812 years
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 postmarketing surveillance requirements.
Behavioural Skills
- Excellent communication and interpersonal skills.
- Efficient team player and a good collaborator.
- Good influencing skills.
- Strong analytical and problemsolving 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 regulatoryspecific software.
- Willingness to travel for regulatory meetings and inspections.
Additional Information :
About the Department
Integrated Product Development Organisation
We integrate our deep science capabilities and cuttingedge technology to develop innovative accessible and affordable therapies for patients worldwide. We are a sciencedriven innovationfocused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs. We are serving 55 markets including USA Canada Europe China LATAM ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API) Oral formulations Parenteral (Injectables Opthalmics) & Other dosages
Our product development efforts drive a portfolio of more than 1000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates we have filed 1071 patents and also published over 1000 papers for peer review over the years.
Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
