Cencora is hiring for the position of Senior Specialist, Regulatory Affairs (CMC, Biologics) in Noida, India. This full-time opportunity is suitable for experienced regulatory affairs professionals with expertise in biologics CMC, IMPD, IND, BLA and MAA writing.

Candidates with a bachelor’s degree in Life Sciences, Pharmacy, Medicine, Nursing, Public Health, Epidemiology, Regulatory Affairs or a related discipline can apply. The position requires 4+ years of Regulatory Affairs experience in biologics CMC.

For professionals looking for Cencora jobs in Noida, Regulatory Affairs jobs in India, CMC Regulatory Affairs jobs, or biologics regulatory affairs careers, this opening offers an opportunity to work on global regulatory projects and interact with clients and Health Authorities.

Cencora Senior Specialist Job Overview

Key Responsibilities

As a Senior Specialist, Regulatory Affairs (CMC, Biologics) at Cencora, the selected candidate will support regulatory projects involving medicinal products and biologics.

Key responsibilities include:

• Develop and maintain professional relationships with clients and identify opportunities for additional service support.
• Participate in regulatory processes required to obtain and maintain marketing authorizations for human and veterinary medicinal products.
• Support regulatory applications, renewals and variations with particular emphasis on Chemistry, Manufacturing and Controls (CMC).
• Prepare, review and compile biologics CMC regulatory documentation.
• Communicate with clients and Health Authorities in coordination with regulatory project leads.
• Support the planning and execution of client projects according to established KPIs.
• Provide CMC-related regulatory guidance to colleagues and clients.
• Maintain current knowledge of regulatory requirements and apply regulatory intelligence to client projects.
• Support regulatory strategy implementation and optimization.
• Follow and support internal regulatory procedures.
• Contribute operational insights to commercial, marketing and business-development activities.
• Provide input for client proposals where required.
• Support project reporting, budgeting and resolution of invoicing-related queries.
• Provide on-site regulatory support to clients when required.
• Train and support junior or newly joined colleagues in relevant activities.

Qualification – Who Can Apply?

Candidates should have a Bachelor’s degree in one of the following areas:

• Pharmacy / Pharmaceutical Sciences
• Life Sciences
• Medicine
• Nursing
• Public Health
• Epidemiology
• Regulatory Affairs
• Related scientific or healthcare disciplines

Equivalent relevant experience may also be considered as specified in the job description.

Certifications in Regulatory Affairs, Pharmacovigilance, Drug Safety, Clinical Safety, Quality Management or Auditing are preferred but are not stated as mandatory.

Can B.Pharm Candidates Apply?

Yes. B.Pharm candidates fall under the Pharmacy qualification specified by Cencora. However, this is not a fresher position. Applicants are expected to have at least 4 years of relevant Regulatory Affairs experience in biologics CMC.

Experience Required

Applicants should have:

4+ years of Regulatory Affairs experience in biologics CMC, particularly involving regulatory writing and documentation for:

• IMPD – Investigational Medicinal Product Dossier
• IND – Investigational New Drug
• BLA – Biologics License Application
• MAA – Marketing Authorisation Application

Candidates with direct experience preparing and reviewing biologics CMC documents will be particularly aligned with the role.

Skills Required

Cencora is looking for candidates with:

• Strong knowledge of Regulatory Affairs and CMC requirements
• Biologics regulatory documentation experience
• Excellent analytical and problem-solving abilities
• Strong attention to detail
• Ability to prioritize multiple projects and deadlines
• Ability to identify issues and recommend appropriate solutions
• Structured and independent working style
• Client relationship management skills
• Ability to train and support junior colleagues
• Small-project leadership capabilities
• Strong written and verbal communication skills
• Ability to communicate regulatory issues and proposed solutions clearly
• Business-fluent English

Why Consider This Cencora Regulatory Affairs Job?

The position provides experienced regulatory professionals with exposure to global Regulatory Affairs and biologics CMC activities. The role combines scientific and regulatory work with client-facing responsibilities, regulatory strategy, Health Authority communication and project execution.

Cencora also states that employee benefit offerings outside the United States vary according to the applicable country and local market practices.

How to Apply

Application Link