Associate, Regulatory Affairs

Sun Pharmaceutical Industries Ltd•Brampton, ON

6d•CA$66,000 - CA$82,500•Hybrid

About The Position

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. Reaching People. Touching Lives.

Requirements

Minimum B. Sc. in a Chemistry, Pharmacy or Life Science discipline combined with at least three (3) to five (5) years of relevant experience within a Canadian and / or USA Regulatory Affairs pharmaceutical environment.
Strong working knowledge of current regulatory guidelines for FDA and / or TPD.
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.

Nice To Haves

Experience with eCTD submissions and knowledge of GMP and QA/QC procedures is preferred.
Knowledge of the use of eCTD Software for preparing and filing submissions preferred.
Strong organizational ability to maintain a complex and high volume of technical information up to date.

Responsibilities

Prepare and / or review submissions to Health Canada and FDA for a variety of dosage forms (solid oral, liquids, topical semisolids and injectables) in eCTD format (e.g. DMFs, ANDS, NDS, ANDA, NDAs, S/NDSs, DINs, CTAs, NCs, INDs, provincial formulary submissions etc.) for the successful registration of drug products for domestic and international markets.
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.
Prepare and file post approval submissions for FDA (CBE supplement, PAS) and TPD (Notifiable Change, Supplement).
Maintain approved product monographs to comply with CRP-PMs.
Maintain approved drug products for FDA (Annual Report) and TPD (Annual Drug Notification).
Review and approve various product labeling components and marketing materials.
Review internal documentation (master batch records, specifications, labeling, product monographs) for adherence to regulatory guidelines.
Assist in global drug product registrations.
Maintain current awareness of regulatory guidelines (Health Canada, FDA, ICH, European Medicines Agency - EMeA, MHRA, Therapeutic Goods Administration –TGA Australia, etc.).
Other duties as required by the Manager.
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