Associate, Regulatory Affairs (Contract)
Brampton, OntarioJob purpose
Prepare and file drug product submissions to the US FDA and Health Canada.
Duties and 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, Therapeutic Goods Administration –TGA Australia, etc.).
- Other duties as required by the Manager.
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
- 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.
Working conditions
- Multidisciplinary office, R&D and manufacturing environment
- Extensive use of computer
- Varied work schedule to meet deadlines, as required
Physical requirements
Office based / Hybrid role
Direct reports
NA
About Us
Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S. We are the eighth-largest generics pharmaceutical company in the U.S., and we are rapidly ramping up our presence in the specialty branded market, with dermatology, ophthalmology, and oncology as key target segments.
Our Values
Sunology, a combination of Sun and Ideology, is the way of life at Sun Pharma. We practice humility, integrity, passion, and innovation.
How We Work
With people at our core, Sun Pharma has built an inclusive and collaborative work culture, where all employees are empowered to pursue their dreams and professional aspirations.
Benefits
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Health & Wellness
We offer comprehensive benefits, including medical, dental, and vision coverage, as well as health and wellness programs.
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Financial
We provide a competitive 401(k) match program and financial wellness programs to support our employees’ short- and long-term financial goals.
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Life, Work & Family
We provide work-life benefits that support our employees beyond their workday.
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About Us Learn more
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Career Areas Learn more
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