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Reg-Cmc-Senior Specialist

3-5 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

 

Senior Specialist – CMC Regulatory Affairs at Cencora, Noida

Job Summary:
Cencora is hiring a Senior Specialist – CMC Regulatory Affairs to manage regulatory activities for human and veterinary medicinal products, medical devices, cosmetics, and herbal products. This role emphasizes Chemistry, Manufacturing, and Controls (CMC) aspects, client relationship management, and regulatory intelligence. Candidates with several years of regulatory affairs experience and a strong life sciences background are encouraged to apply.


Key Responsibilities:

  • Participate in regulatory processes to gain and maintain marketing authorizations for medicinal and healthcare products with a focus on CMC.

  • Prepare, review, and compile CMC documents for regulatory affairs projects.

  • Communicate with clients and health authorities to support regulatory submissions.

  • Assist with planning and execution of client projects as per KPIs.

  • Provide consultancy to colleagues and clients regarding CMC services.

  • Stay updated on regulatory intelligence and share insights with the team.

  • Support VDC strategy implementation and internal process optimization.

  • Offer operational insights to support business development and marketing activities.

  • Deliver on-site regulatory support to GCS clients when required.


Required Skills & Qualifications:

  • Education: University degree in Life Sciences.

  • Experience: Several years of experience in CMC regulatory affairs or related fields.

  • Advanced knowledge of regulatory processes, particularly CMC.

  • Strong ability to manage multiple projects and prioritize tasks effectively.

  • Problem-solving and analytical skills with a structured and detail-oriented approach.

  • Ability to train and support junior colleagues and lead small projects.

  • Excellent communication skills (written and verbal) with a confident presence.

  • Fluency in business English.


Perks & Benefits:

  • Competitive compensation package (as per market standards).

  • Opportunity to work with global clients and cutting-edge regulatory projects.

  • Professional growth through training and mentorship.

  • Supportive and collaborative workplace culture.


Company Description:

Cencora, through its subsidiary PharmaLex India Pvt. Ltd., is a global leader in regulatory affairs and consulting services for the pharmaceutical, biotechnology, and healthcare sectors. The company’s mission is to create healthier futures by delivering expert-driven regulatory and compliance solutions.


Work Mode: On-site (Noida, India)


Call-to-Action:

If you have expertise in CMC regulatory affairs and want to advance your career with a global leader, apply now for the Senior Specialist – CMC Regulatory Affairs role at Cencora.