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Manager- Spm- Regulatory Affairs

6-10 years
₹18,00,000 – ₹28,00,000 per annum
10 May 23, 2025
Job Description
Job Type: Full Time Education: B.Pharm/M.Pharm 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 Title: Manager – SPM – Regulatory Affairs
Location: Noida, India
Category: Consulting
Job Type: Full Time
Posted Date: May 17th, 2025
Job ID: R257073
Salary Estimate: ₹18,00,000 – ₹28,00,000 per annum (based on experience and market trends)


About Cencora

At Cencora, our people are central to our mission of creating healthier futures. We foster an environment where each team member’s contribution matters, and innovation drives positive change for health worldwide. Join us to make a meaningful impact.


Job Details

As a Manager in SPM – Regulatory Affairs, you will be pivotal in managing regulatory projects related to human and veterinary medicinal products, medical devices, cosmetics, food supplements, and herbal products. Your role includes maintaining strong client relationships, ensuring compliance with EU regulatory requirements, and supporting strategic regulatory initiatives.

Responsibilities:

  • Develop and maintain strong relationships with clients, supporting your Line Manager to identify opportunities for enhanced service delivery.

  • Participate actively in regulatory processes for marketing authorizations, including applications, renewals, and variations for medicinal products and related categories.

  • Prepare, review, and compile regulatory documentation within project frameworks.

  • Communicate effectively with clients and Health Authorities to facilitate regulatory submissions and inquiries.

  • Support scientific advice procedures and represent clients in interactions with health authorities.

  • Plan and execute client projects aligned with KPIs, coordinating internal teams and qualified external partners.

  • Provide regulatory guidance and consultancy to colleagues and clients regarding strategy and procedure management.

  • Maintain and share regulatory intelligence to keep projects aligned with current regulatory requirements.

  • Deliver seminars and lectures for internal teams, clients, and professional audiences to disseminate regulatory knowledge.

  • Support VDC (Veterinary Drug Consulting) strategy implementation and optimization efforts.

  • Contribute to internal process improvements and ensure compliance with quality standards.

  • Assist commercial, marketing, and business development activities led by VDC, including input on proposals.

  • Support delivery to budget targets with accurate reporting and assist in resolving invoicing queries.

  • Provide on-site regulatory support to clients as agreed with management.

  • Perform other reasonable tasks related to the role as assigned in agreement with management.


Qualifications & Experience

  • Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm).

  • 6 to 10 years of experience in Regulatory Affairs, preferably in pharmaceuticals and including cosmetics, food supplements, and/or herbal products.

  • Experience with the EU regulatory submission process.

  • Solid knowledge of EU regulatory disciplines and labelling regulations.

  • Excellent verbal and written communication skills.

  • Strong attention to detail and accuracy in all regulatory documentation.


What Cencora Offers

Benefits vary by country and align with local market practices. Eligibility and effective dates may differ based on country and collective bargaining agreements.


Affiliated Company: PharmaLex India Private Limited

Equal Employment Opportunity:
Cencora is an equal opportunity employer committed to a diverse and inclusive workplace. We comply with all applicable laws prohibiting discrimination and harassment. Reasonable accommodations are available for applicants with disabilities during the hiring process.