Instagram
youtube
Facebook

Assistant Manager, Regulatory Affairs

3-6 years
Not Disclosed
10 July 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Summary

Cencora, through its affiliate PharmaLex India Pvt. Ltd., is seeking an Assistant Manager – Regulatory Affairs in Noida, India (On-site). This role focuses on CMC documentation, marketing authorization submissions, renewals, variations, and regulatory consulting across pharmaceuticals, medical devices, cosmetics, and herbal products. If you have a proven background in regulatory affairs and are ready to collaborate with global clients and health authorities, this role offers excellent career progression.

Salary / Compensation Range: Not mentioned in the job description.


Key Responsibilities

  • Manage regulatory submissions for human and veterinary medicines, medical devices, cosmetics, and herbal products, focusing on CMC aspects.

  • Prepare, review, and compile CMC documentation for regulatory projects.

  • Build and maintain client relationships, supporting business development and service expansion.

  • Provide scientific advice and represent clients in discussions with health authorities.

  • Plan, coordinate, and execute projects according to KPIs with both internal and external partners.

  • Deliver regulatory consultancy to colleagues and clients on CMC services.

  • Conduct regulatory intelligence and share insights with the team.

  • Prepare and present seminars, lectures, and professional updates for internal and client stakeholders.

  • Support the implementation of VDC strategy, process optimization, and internal quality systems.

  • Contribute to commercial and proposal activities and ensure timely and accurate reporting for project budgeting.

  • Provide on-site regulatory support for global clients as required.


Required Skills & Qualifications

  • Bachelor’s or Master’s degree in Pharmaceutical Sciences, Regulatory Affairs, Life Sciences, or a related field.

  • Proven experience in regulatory submissions, CMC documentation, and health authority communications.

  • Strong understanding of marketing authorization procedures (applications, renewals, variations).

  • Familiarity with medical devices, cosmetics, herbal products, and food supplements regulations.

  • Strong organizational and project management skills.

  • Ability to manage multiple stakeholders and work under strict regulatory timelines.

  • Excellent communication, documentation, and presentation skills.

  • Knowledge of regulatory intelligence and compliance best practices.


Perks & Benefits

  • Career development opportunities in a global regulatory and consulting leader.

  • Exposure to international regulatory projects and client portfolios.

  • Inclusive and diverse workplace culture.

  • Access to training programs and industry seminars.


About Cencora (PharmaLex India Pvt. Ltd.)

Cencora is a leading healthcare and consulting organization committed to building healthier futures. Through PharmaLex India, it offers expertise in regulatory affairs, quality compliance, pharmacovigilance, and consulting services, serving top pharmaceutical and biotech companies globally.


Work Mode

On-site | Noida, India | Full-time


Apply Now

Ready to advance your career in regulatory affairs and CMC consulting with a global leader? Apply today and join Cencora’s expert team.