Drug Regulatory Affair

4 weeks ago

Chandigarh Chandigarh, India Maya Biotech PVT LTD Full time

**Position**: Drug Regulatory Affairs Executive
**Industry**: Pharmaceutical Manufacturing (Third-Party Manufacturer)
**Location**: Chandigarh, Baddi

**About Us**

We are a leading pharmaceutical company specializing in injectable formulations. With a strong commitment to quality and regulatory compliance, we provide innovative and high-quality solutions for pharmaceutical brands globally.

**Key Responsibilities**
- Independently prepare, compile, and review regulatory dossiers for export markets, ensuring compliance with country-specific regulatory requirements.
- Manage end-to-end regulatory submissions, including obtaining approvals for new product registrations, renewals, and variations.
- Maintain up-to-date knowledge of international regulatory guidelines (e.g., USFDA, EU GMP, WHO GMP, etc.) and ensure adherence to all relevant standards.
- Liaise with clients and regulatory authorities to address queries and ensure timely approvals.
- Coordinate with internal teams (e.g., quality assurance, production, R&D) to collect necessary documentation for dossier preparation.
- Track and manage regulatory timelines and deliverables to ensure smooth product registrations in multiple markets.
- Assist in the preparation and review of technical documents, including specifications, stability data, and validation reports.
- Support audits and inspections by regulatory bodies as required.

**Qualifications and Skills**
- **Experience**: Minimum 2-4 years in Drug Regulatory Affairs within the pharmaceutical industry, with a focus on injectables and third-party manufacturing.
- Proven ability to independently prepare and manage dossiers for export markets.
- Strong understanding of global regulatory requirements and guidelines.
- Excellent communication and interpersonal skills for effective collaboration with clients and regulatory bodies.
- Proficiency in documentation and attention to detail.
- **Education**: Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.

**Job Types**: Full-time, Permanent

Pay: ₹20,000.00 - ₹30,000.00 per month

Schedule:

- Morning shift

Work Location: In person

  • Agm/dgm Drugs Regulatory Affairs

    7 months ago

    Chandigarh, India Ind-Swfit Full time

    **Roles and Responsibilities** - Provide comprehensive regulatory support throughout the product lifecycle, including vendor selection, API development, scale-up, validation, dossier filing, query handling, and post-approval life cycle management. - Support the Analytical Research Development and Chemical Research Division in the development of new APIs and...

  • Regulatory Affairs Officer

    6 months ago

    Chandigarh, India MEDVARSITY ONLINE LIMITED Full time

    Position: Regulatory Senior Consultant/ Consultant - CMC Location: Hybrid (80 % remote, 20 % In office) Reports To: Manager or above, Regulatory Affairs unctional Responsibilities - Work with global clients on regulatory filing projects for USFDA, EMA, MHRA, APAC, Canada etc. The key delivery areas include Pre and Post approval CMC authoring, preparation,...

  • Drug Safety Physician

    7 months ago

    Chandigarh, India MEDVARSITY ONLINE LIMITED Full time

    Drug Safety Physician role. Attached is the JD for your reference. Experience required: 0 - 2 years Qualification requirements: MBBS or MD Vacancies: 5 Work Location: Chandigarh Office Job responsibilities: - Providing medical advice to PV Scientists to assist them with processing of ICSRs - Review of published literature articles/abstracts -...

  • Faculty Position in Pharmaceutical Sciences

    6 days ago

    Chandigarh, Chandigarh, India Chitkara University Full time

    Company OverviewChitkara University is a leading institution in the field of pharmacy, ranked 19th for Pharmacy by NIRF 2024. Our university offers various programs in pharmaceutical sciences, including B.Pharm, Pharm.D., Pharm.D. (Post Baccalaureate), M Pharmacy and M.Sc. Pharmacovigilance & Clinical Research.Salary Range: ₹ 8-12 Lakhs per annumJob...

  • Chitkara University | Assistant Professor-Chitkara College of Pharmacy | chandigarh

    1 month ago

    chandigarh, India Chitkara University Full time

    Chitkara University is looking for Assistant & Associate Professor in Chitkara School of Pharmacy at Chitkara University, Punjab and Himachal Pradesh.Chitkara College of Pharmacy has been ranked 19th for Pharmacy by NIRF 2024. The College offers full-time courses in the areas of Pharmacy, which include B. Pharm, Pharm.D., Phar.D. (Post Baccalaureate), M...

  • Academic Faculty Member for Pharmacy Program

    6 days ago

    Chandigarh, Chandigarh, India Chitkara University Full time

    Chitkara University, a renowned institution in Punjab and Himachal Pradesh, invites applications for the position of Assistant & Associate Professor in Chitkara School of Pharmacy. This esteemed college has been ranked 19th for Pharmacy by NIRF 2024 and offers full-time courses in pharmacy, including B. Pharm, Pharm.D., Phar.D. (Post Baccalaureate), M...

  • Assistant Professor-Chitkara College of Pharmacy

    1 month ago

    Chandigarh, India Chitkara University Full time

    Chitkara University is looking for Assistant & Associate Professor in Chitkara School of Pharmacy at Chitkara University, Punjab and Himachal Pradesh.Chitkara College of Pharmacy has been ranked 19th for Pharmacy by NIRF 2024. The College offers full-time courses in the areas of Pharmacy, which include B. Pharm, Pharm.D., Phar.D. (Post Baccalaureate), M...

  • Assistant Professor-Chitkara College of Pharmacy

    1 month ago

    Chandigarh, India Chitkara University Full time

    Chitkara University is looking for Assistant & Associate Professor in Chitkara School of Pharmacy at Chitkara University, Punjab and Himachal Pradesh. Chitkara College of Pharmacy has been ranked 19th for Pharmacy by NIRF 2024. The College offers full-time courses in the areas of Pharmacy, which include B. Pharm, Pharm.D., Phar.D. (Post Baccalaureate), M...

  • Chitkara University | Assistant Professor-Chitkara College of Pharmacy | chandigarh

    1 month ago

    chandigarh, India Chitkara University Full time

    Chitkara University is looking for Assistant & Associate Professor in Chitkara School of Pharmacy at Chitkara University, Punjab and Himachal Pradesh. Chitkara College of Pharmacy has been ranked 19th for Pharmacy by NIRF 2024. The College offers full-time courses in the areas of Pharmacy, which include B. Pharm, Pharm.D., Phar.D. (Post Baccalaureate), M...

  • Chitkara University | Assistant Professor-Chitkara College of Pharmacy | chandigarh

    1 month ago

    chandigarh, India Chitkara University Full time

    Chitkara University is looking for Assistant & Associate Professor in Chitkara School of Pharmacy at Chitkara University, Punjab and Himachal Pradesh.Chitkara College of Pharmacy has been ranked 19th for Pharmacy by NIRF 2024. The College offers full-time courses in the areas of Pharmacy, which include B. Pharm, Pharm.D., Phar.D. (Post Baccalaureate), M...

  • Assistant Professor-Chitkara College of Pharmacy

    1 month ago

    Chandigarh, India Chitkara University Full time

    Chitkara University is looking for Assistant & Associate Professor in Chitkara School of Pharmacy at Chitkara University, Punjab and Himachal Pradesh.Chitkara College of Pharmacy has been ranked 19th for Pharmacy by NIRF 2024. The College offers full-time courses in the areas of Pharmacy, which include B. Pharm, Pharm.D., Phar.D. (Post Baccalaureate), M...

  • Academic Professor Position in Pharmaceutical Sciences

    4 weeks ago

    Chandigarh, Chandigarh, India Chitkara University Full time

    Chitkara University, a renowned institution of higher learning, is seeking an exceptional academic professional to fill the position of Assistant Professor in the Chitkara School of Pharmacy. Located in Punjab and Himachal Pradesh, our university offers a dynamic and supportive environment for growth and development.The Chitkara College of Pharmacy has...

  • Chitkara University | Assistant Professor-Chitkara College of Pharmacy | chandigarh

    1 month ago

    Chandigarh, India Chitkara University Full time

    Chitkara University is looking for Assistant & Associate Professor in Chitkara School of Pharmacy at Chitkara University, Punjab and Himachal Pradesh.Chitkara College of Pharmacy has been ranked 19th for Pharmacy by NIRF 2024. The College offers full-time courses in the areas of Pharmacy, which include B. Pharm, Pharm.D., Phar.D. (Post Baccalaureate), M...

  • Deputy manager quality

    2 weeks ago

    Chandigarh, India Domnic Lewis International Full time

    We are looking for a Deputy Manager Quality – South Asia & Middle East for a Global Medical Equipment Manufacturing MNC based in Chandigarh. Position: Deputy Manager Quality – South Asia & Middle East Qualification: Masters in life science + Certification in ISO 13485 auditing Experience: 5-10 years Location: Chandigarh-Punjab Job...

  • Zoe MedCare | Medical Writer

    10 hours ago

    Chandigarh, India Zoe MedCare Full time

    Company DescriptionZoe MedCare specializes in high-quality medical writing solutions, focusing on regulatory writing and medical communication to support the drug development process. The team delivers clear, accurate, and compliant documents tailored for pharmaceutical and biotech companies, bridging the gap between scientific data and effective...

  • Deputy Manager Quality – South Asia

    3 weeks ago

    Chandigarh, India Domnic Lewis International Full time

    We are looking for a Deputy Manager Quality – South Asia & Middle East for a Global Medical Equipment Manufacturing MNC based in Chandigarh.Position: Deputy Manager Quality – South Asia & Middle EastQualification: Masters in life science + Certification in ISO 13485 auditingExperience: 5-10 yearsLocation: Chandigarh-PunjabJob description:This position...

  • Domnic lewis international | deputy manager quality – south asia

    2 weeks ago

    Chandigarh, India Domnic Lewis International Full time

    We are looking for a Deputy Manager Quality – South Asia & Middle East for a Global Medical Equipment Manufacturing MNC based in Chandigarh.Position: Deputy Manager Quality – South Asia & Middle EastQualification: Masters in life science + Certification in ISO 13485 auditingExperience: 5-10 yearsLocation: Chandigarh-PunjabJob description:This position...

  • Medical Writer

    10 hours ago

    Chandigarh, India Zoe MedCare Full time

    Company DescriptionZoe MedCare specializes in high-quality medical writing solutions, focusing on regulatory writing and medical communication to support the drug development process. The team delivers clear, accurate, and compliant documents tailored for pharmaceutical and biotech companies, bridging the gap between scientific data and effective...

  • Zoe MedCare | Medical Writer

    2 days ago

    chandigarh, India Zoe MedCare Full time

    Company DescriptionZoe MedCare specializes in high-quality medical writing solutions, focusing on regulatory writing and medical communication to support the drug development process. The team delivers clear, accurate, and compliant documents tailored for pharmaceutical and biotech companies, bridging the gap between scientific data and effective...

  • Medical Writer

    2 days ago

    Chandigarh, India Zoe MedCare Full time

    Company DescriptionZoe MedCare specializes in high-quality medical writing solutions, focusing on regulatory writing and medical communication to support the drug development process. The team delivers clear, accurate, and compliant documents tailored for pharmaceutical and biotech companies, bridging the gap between scientific data and effective...