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Senior Specialist-Spm-Regulatory Affairs

2-5 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 – Regulatory Affairs at Cencora, Noida

Job Summary:
Cencora is seeking a highly skilled Senior Specialist – Regulatory Affairs with 2-5 years of experience in regulatory submissions, labeling, and EU regulatory affairs. This role involves supporting regulatory processes for human and veterinary medicinal products, cosmetics, food supplements, and herbal products. Candidates with a strong pharma background and expertise in EU submission processes are encouraged to apply.


Key Responsibilities:

  • Participate in regulatory processes for marketing authorizations, renewals, and variations for human/veterinary medicinal products and other healthcare products.

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

  • Communicate with clients and health authorities for regulatory submissions.

  • Provide regulatory strategy guidance and consultancy for clients and internal teams.

  • Manage client projects as per KPIs, including team coordination and partner management.

  • Support scientific advice procedures and represent clients before health authorities.

  • Develop and maintain regulatory knowledge and share expertise with colleagues.

  • Present seminars, lectures, and contribute to professional forums.

  • Ensure compliance with internal processes and regulatory guidelines.

  • Provide on-site regulatory support to clients as required.


Required Skills & Qualifications:

  • Qualification: B.Pharm or M.Pharm.

  • Experience: 2–5 years in Regulatory Affairs within the pharmaceutical industry.

  • Strong knowledge of EU submission processes, labeling regulations, and regulatory affairs disciplines.

  • Prior experience with cosmetics, food supplements, and herbal products is an advantage.

  • Excellent verbal and written communication skills.

  • Attention to detail, accuracy, and strong organizational skills.


Perks & Benefits:

  • Competitive salary package (as per industry standards).

  • Opportunity to work with global pharmaceutical and healthcare regulatory projects.

  • Professional growth through training, seminars, and expert-led sessions.

  • Collaborative work culture with career advancement opportunities.


Company Description:

Cencora, through its subsidiary PharmaLex India Pvt. Ltd., is a global leader in consulting and regulatory affairs, dedicated to delivering high-quality solutions to the pharmaceutical, biotechnology, and healthcare industries. Cencora’s mission is to create healthier futures by combining scientific expertise with innovative solutions.


Work Mode: On-site (Noida, India)


Call-to-Action:

If you are an experienced regulatory affairs professional seeking a challenging and rewarding role, apply now for the Senior Specialist – Regulatory Affairs position at Cencora.