Title:  Senior Associate, Regulatory Affairs (Contract)

Job purpose

The goal of the Senior Regulatory Affairs Associate is to plan, coordinate, compile, submit, obtain approval, and maintain drug product registrations for the US, Canada, EU, UK & Australia as well as assist global drug product registrations.

Duties and responsibilities

• Plan, coordinate, compile and file drug product submissions for Canada and the U.S. for a variety of dosage forms (solid oral, liquids, topical semisolids and injectables) in eCTD format to Canada & US (e.g. DMFs, ANDS, NDS, ANDA, NDAs, S/NDSs, DINs, CTAs, NCs, INDs, provincial formulary submissions etc.) for the successful registration of drug product for domestic and international markets.
• Support in preparation for regulatory filing to EU, UK & Australia.
• 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. 
• Plan, coordinate, compile and file post approval submissions for FDA (CBE supplement, PAS) and Health Canada (Supplement). 
• Review Change Controls and determine filling requirements for all markets.
• Liaise with Health Canada and Provincial regulators on all aspects of the drug submission, follow up for review status and project updates.
• Review submissions prepared by associates and senior associates.
• Work on more complex projects which involve identifying and resolving issues in a timely manner.
• Review and approve various product labeling components and marketing materials.
• In consultation with the manager, provide regulatory guidance and expertise to Sales & Marketing, R&D, QC/QA, and Operations departments of Sun Pharma organization.
• Assist in preparation and compilation of FDA and Health Canada pre-approval and GMP inspections.
• Maintain current awareness of regulatory guidelines (Health Canada, FDA, ICH, EMeA, UK-MHRA, 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
• At least five (5) to seven (7) years of hands-on Regulatory Affairs experience of filing and managing Canadian and USA submissions, including electronic submissions in eCTD formats.
• Expertise in chemistry and manufacturing, labeling and format requirements for drug product registration for FDA (ANDA, NDA, DMF, IND) and Health Canada (CTA, ANDS, S/ANDS, NDS, DIN, DMF). 
• Knowledge of the use of eCTD Software for preparing and filing submissions preferred.
• Knowledge of GMP requirements and QA/QC procedures. 
• Excellent interpersonal, written and verbal communication skills. 
• Ability to plan, coordinate and work effectively in a team-oriented environment. 
• Ability to independently prepare written responses to deficiency letters from regulatory agencies, as well as obtain approval of changes to approved drug products.
• Superior computer software skills (Microsoft Word, Excel, Access, PowerPoint, Adobe Acrobat, Document Management Systems, Artwork management system).
• Strong organizational ability and management of multiple priorities combined with proven ability to meet strict and established timelines. 
• Multi-tasking various tasks and adhering to strict timelines.

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 role