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Specialist - Regulatory Affairs

3-7 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 Title

Specialist – Regulatory Affairs

Location

Noida, India

Category

Consulting

Employment Type

Full time

Posted Date

July 2, 2025

Job ID

R2511049

Work Mode

Hybrid / On-site as needed (providing on‑site regulatory support to clients per project requirements)

Compensation / Salary

Not disclosed in the job description. (Position states a competitive salary and benefits package aligned to local market practice.)


Job Summary (Pharma/Healthcare-Focused)

Cencora (affiliated with PharmaLex India Private Limited) is seeking a Regulatory Affairs Specialist in Noida to drive end-to-end regulatory lifecycle management for human and veterinary medicinal products, medical devices, cosmetics, food supplements, and herbal products. You will contribute to marketing authorization applications (MAAs), renewals, and variations, compile and review regulatory dossiers, communicate with Health Authorities, and support VDC (Virtual Development Center) strategy implementation. This client-facing role demands meticulous attention to detail, proven RA process knowledge, strong documentation skills, and the ability to manage multiple projects against defined KPIs.


Key Responsibilities

  • Participate in regulatory procedures to gain and maintain marketing authorizations (applications, renewals, variations) for human/veterinary products, medical devices, cosmetics, food supplements, and herbal products.

  • Prepare, review, and compile regulatory documents in line with project requirements and internal procedures.

  • Liaise with clients and Health Authorities in close cooperation with the respective lead.

  • Support planning and execution of client projects against KPIs and timelines.

  • Provide operational insights to VDC-led commercial, marketing, and business development activities (including proposal input).

  • Guide colleagues and clients on Regulatory Strategy and Procedure Management.

  • Contribute to VDC strategy implementation and optimization.

  • Ensure compliance with internal SOPs and quality standards.

  • Assist respective lead with budget delivery, timely reporting, and addressing invoicing queries.

  • Provide on-site regulatory support to GCS clients when agreed with Head of VDC REG.

  • Perform other reasonable, role-aligned tasks as assigned by leadership.


Required Skills & Qualifications

  • University degree in Life Sciences (e.g., Pharmacy, Biotechnology, Biomedical Sciences).

  • Several years’ experience (commonly 3–7 years) in Regulatory Affairs or closely related functions, with demonstrable capability to handle more complex tasks.

  • Strong understanding of regulatory submissions, lifecycle management, KPIs, and dossier compilation.

  • Proven ability to prioritize parallel tasks, escalate appropriately, and propose practical solutions.

  • Structured, systematic, and independent working style with keen attention to detail and high service orientation.

  • Ability to train/support junior colleagues and lead small, clearly scoped projects.

  • Strong client and stakeholder management skills at an operational/day-to-day level.

  • Business-fluent English with excellent written and verbal communication skills.

(If you want this tailored to CMC, eCTD/CTD Modules, or specific regions like CDSCO/EU/US-FDA for stronger keyword targeting, let me know.)


Perks & Benefits

  • Competitive salary and benefits package aligned with local market practice.

  • Opportunity to work on diverse global regulatory portfolios across pharma, medical devices, cosmetics, and herbal products.

  • Collaborative, supportive consulting environment with strong focus on quality and compliance.

  • Professional growth within a globally recognized healthcare organization focused on creating healthier futures.


Company Description

Cencora is a global healthcare leader dedicated to creating healthier futures by improving access, compliance, and outcomes across the health ecosystem. Through PharmaLex India Private Limited, the company delivers end-to-end regulatory affairs consulting, strategy, submissions, and compliance services to top-tier life sciences clients worldwide.


Call-to-Action

Ready to advance your Regulatory Affairs career with a global healthcare leader? Apply now with your updated CV, detailing your experience in MAAs, renewals, variations, dossier compilation, and Health Authority interactions, along with notice period and current CTC.