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.
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