Senior Specialist, Regulatory Affairs (CMC, Biologics)

Cencora
Full Time
₹6 Lakhs - ₹12.4 Lakhs
APAC, Noida, India
Posted 1h ago

Senior Specialist, Regulatory Affairs (CMC, Biologics)

Cencora

Job description

Looking to build a career in biologics regulatory affairs? Explore this Senior Specialist, Regulatory Affairs (CMC, Biologics) role at Cencora in Noida.

 Company Description  

Cencora is a leading global pharmaceutical solutions company focused on improving lives for people and animals everywhere. The company connects manufacturers, providers, and patients, helping people access the therapies they need, when and where they need them. As a purpose driven organization, Cencora's global teams work together to create healthier futures. Its affiliated company, PharmaLex India, supports strong regulatory expertise across the region.

 Job Summary  

This job is located in Noida. Deals with regulatory affairs for biologics CMC projects. As a Senior Specialist you will be involved in the marketing authorization processes, for veterinary medicines. You will assist in creating and checking biologics CMC documents. You will work very closely with clients and health authorities. This job also includes helping with project planning, developing strategy and giving guidance to other team members and clients.

 Key Responsibilities 

  • Maintain strong client relationships and spot chances for added support within client relationships.

  • support processes for marketing authorizations, renewals and variations ensuring regulatory processes run smoothly.

  • Help prepare, review and compile biologics CMC documents for projects focusing on biologics CMC documents.

  • Communicate with clients and health authorities alongside the project lead ensuring communication with clients and health authorities.

  • Support planning and delivery of client projects in line with agreed KPIs aligning planning and delivery with client projects.

  • Offer guidance to colleagues and clients on CMC related services providing guidance, on CMC related services.

  • Maintain strong regulatory knowledge and share regulatory knowledge with the team.

  • Support the implementation and improvement of strategy strengthening regulatory strategy.

  • Help maintain internal company procedures maintaining internal company procedures.

  • Support business development activities, including proposal input contributing to commercial and business development activities.

  • Help track budgets and respond to invoicing related queries, managing budgets.

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

  • Take on other reasonable tasks as agreed with your line manager.

 Educational Qualification 

  • Bachelor's degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience.

  • Certification in pharmacovigilance, drug safety, regulatory affairs, clinical safety, or quality management is preferred.

 Skills Required 

  • At least 4 years of experience in regulatory affairs, with a focus on biologics CMC, IMPD, IND, BLA, or MAA writing.

  • Ability to manage multiple tasks and prioritize work effectively.

  • Strong attention to detail and a high service oriented mindset.

  • Ability to work independently, with systematic approach.

  • Ability to guide and support colleagues and lead small projects.

  • Strong skills in managing both internal and client relationships.

  • Excellent written and verbal communication skills.

  • Confident, professional manner, with fluent business level English.

 Salary Structure 

The salary for a Senior Specialist, Regulatory Affairs at Cencora typically ranges from ₹6 Lakhs to ₹12.4 Lakhs per year.

 Career Development  

This role offers strong exposure to global biologics regulatory work within a purpose driven pharmaceutical solutions company. Cencora also supports long term growth through structured benefits, mentorship, and opportunities to lead larger regulatory projects over time.

 How to Apply  

  • Visit our job portal and search for the Senior Specialist, Regulatory Affairs role - Cencora.

  • Click on the job posting to read all the details, about the job.

  • Fill in your details. Upload your updated resume.

  • Send your application.

Employment Type: Full Time
Industry: Healthcare
Role Category: Pharmacy
Application: External (Company Site)

Key Skills

PharmacyDoctorsNursesMedical Science LiaisonNon Clinical JobsClinical Research

Market insights & trends

Salary Insights

The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.

Hiring Trends

The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.

Frequently Asked Questions

Everything you need to know about the process

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Not all cities are equal on this front, and applying blindly wastes time. Bangalore is where health-tech and clinical research hiring is concentrated. Hyderabad is pharma country – manufacturing, QC, formulation, R&D. Mumbai and Navi Mumbai handle specialized hospital care, advanced nursing roles, and pharmacovigilance admin, medical writing, policy work all coexist there without one dominating the other. If you're open to relocating, knowing this upfront changes which jobs you even bother applying for.
Both. That's the honest answer. Legitimate remote roles in healthcare have existed long before anyone started calling things "hybrid." Medical Coders, Pharmacovigilance Associates, Telehealth Coordinators, Freelance Medical Writers — these positions have been hiring remotely for years through companies that are very much real. The fake ones almost always have one thing in common: they ask for money. Registration fees, document processing charges, security deposits — whatever the label, it's a scam. No actual employer takes money from a candidate before they join. That rule holds without exception.
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Short answer: yes, and it's happening constantly. Long answer: it depends on what you want. If structured hours, no emergency calls, and a salary that doesn't plateau after three years sound appealing — corporate healthcare is worth your attention. Medical Writing, Drug Safety Review, Insurance Auditing, Health-tech Program Management — these roles specifically want people who understand clinical realities. A nursing degree or MBBS isn't a handicap here. It's often the reason you get the interview.