Intern, Regulatory Affairs

Driven by a bold pursuit of science and fueled by an unwavering commitment to patients, Sun Pharma is a leading global pharmaceutical company, providing high-quality medicines trusted by healthcare professionals and patients.

As part of our mission to Reach People and Touch Lives, we deliver Innovative Medicines, Generics and Consumer Healthcare products that improve the lives of millions of people. With a broadly diversified portfolio of products that span multiple therapeutic areas, we improve access to effective, affordable treatments that promote better health and well-being.

Job purpose

To support regulatory activities for the Canadian market with hands-on exposure to the Health Canada requirements, product registrations, labeling compliance, and rebranding submissions.

Duties and responsibilities

• Assist in preparing and reviewing submission packages in compliance with Health Canada regulations, including Administrative and Labelling Only submissions.
• Support regulatory tasks related to product rebranding initiatives, conducting gap analyses between existing and proposed labels & Labeling revisions.
• Review labels, cartons, inserts, and Prescribing Information for compliance.
• Compiling rebranding submission documentation (updated mock-ups, attestations etc.)
• Facilitating internal artwork routing and regulatory approval steps.
• Work closely with Quality Assurance, Marketing, Supply Chain, and Packaging/Artwork teams.
• Support regulatory input during product changes, rebranding workflows, and market readiness projects.
• Prepare submissions in eCTD format which involves full understanding of the use of Adobe Acrobat to create bookmarks and links.
• Prepare written responses to deficiency letters from regulatory agencies in the stated time frame.
• Participate in project meetings to help ensure regulatory compliance across product lifecycles.

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• Currently enrolled in or recently completed a degree in Under grad (open to 1st year to 3rd year students. Diploma - Regulatory affairs, Pharmacy (BSc/PharmD), Pharmaceutical Sciences, Life Sciences or Biology, Chemistry, Biomedical Sciences, Regulatory Affairs Certificate Program.
• Strong organizational ability to maintain a complex and high volume of technical information up to date.
• Proficiency with applicable computer software – Microsoft Office including Word, Excel and PowerPoint and Adobe Acrobat and Document Management Systems.
• Excellent interpersonal, written and verbal communication skills. 
• Ability to plan, coordinate and work effectively in a team-oriented environment.

Working conditions

• Multidisciplinary office, R&D and manufacturing environment
• Extensive use of computer
• Varied work schedule to meet deadlines, as required

Physical requirements

5 days onsite, Office based at Brampton

Direct reports

NA