Job Description

Senior Manager, Regulatory Affairs The Senior Manager, Regulatory Affairs will lead and guide our clients on matters relating to regulatory pathways, submission/dossier preparations, issue resolution, and compliance to regulations and expectations for pharmaceuticals and healthcare products in development and beyond. This role requires a special regulatory affairs expert with a breadth of experience in different regulatory jurisdictions, especially the U.S., Canada, and Europe, a deep understanding of how regulatory affairs contributes to product development, and a love of the challenges that come with working on fast-moving development programs. A s the Senior Manager, Regu l ato r y A ff a i r s, y ou w il l w o r k w i th other i n - hou s e Regu l ato r y A ff a i r s p r o f e ss i ona l s on the da y - to - day tasks associated w i th r egu l ato r y a ff a i rs and provide hands on leadership to the regulatory affairs team in the p r epa r at i on of do m e s t i c and i nte r nat i onal r egu l ato r y s ub m i ss i ons and providing advice on impact of ongo i ng c hanges i n r egu l ato r y and c o m p li an c e po li c i es and p r o c edu r e s . This is an immediate opening based out of our Mississauga, Ontario, Canada office. R esponsibilities :

• Provide strategic advice and leadership to advance development of products worldwide and ensuring efficient progress from research to First-in-Human, Proof of Concept and Pivotal Studies through to marketing. Provision of product development plans and development and implementation of detailed strategies. Keep abreast of relevant regulatory changes and inform group if and as necessary.
• Manage and coordinate Regulatory Agency negotiations and meetings, e.g., FDA, Health Canada. Address questions from and facilitate meetings or liaison with regulatory agencies on behalf of clients.
• Lead and guide the writing and/or review of regulatory documents such as strategy documents, gap assessments, regulatory agency meeting materials, designation requests, etc.
• Actively participate the preparation and oversee operational regulatory activities necessary to prepare regulatory submissions. Writing, managing and preparing all types of global dossiers for regulatory submissions in the U.S., and Canada for products such as pharmaceuticals, biologics, medical devices, e.g., pre-meeting packages, IND/CTAs, NDS/NDA/BLA, amendments, notifications, DMFs, 510(K), PMA, etc.
• Be a senior consultant, able to identify and generate new business and actively market Intertek’s Pharmaceutical and Healthcare services. Attract a flow of work from new and existing clients based on own reputation and expertise in the field. Maintain successful, long-term business relationships with representative companies in the global Pharmaceutical & Healthcare field.
• Act as a senior leader for the team : support leadership in meeting goals and objectives and contribute to the development of junior staff.

• Undergraduate Degree, MSc/M.S., PhD ; 8+ y ea r s of r egu l ato r y e x pe r i en c e i n an i ndu s t r y s ett i ng.
• R A C c e r t i f i c at i on p r e f e rr ed.
• Consulting experience preferred.
• Subject matter expertise: K no w l edge of p r odu c t de v e l op m ent, up-to-date r egu l ato r y knowledge of U.S. and Canadian pharmaceutical and healthcare regulatory requirements .
• Demonstrated success in dossier preparation to Regulatory Agencies and experience in attending and leading a team to prepare for Agency interactions.

• Excellent communication skills in both verbal and written format; able to develop persuasive, clear arguments and rationales.
• G ood te c hn i c al w r i t i ng s k ill s and the ab ili ty to r e vi ew and cr i t i que s a f et y , e ff i c a c y , and qua li t y submission documents .
• Enjoys the challenge of analyzing and solving problems.
• E xc e ll ent i nte r pe rs onal s k il ls and o r gan i z at i ona l , t i m e m anage m en t , and c o mm un i c at i on s k ill s a r e e ss ent i a l for client and internal team interactions .
• Able to self -motivate to meet project or submission timelines, process information, and work independently in a fast-paced, multi-tasking environment, but also a team player able to contribute work on a number of different parts of a project.
• Able to work remotely (home-based) or in an office in Mississauga, Ontario, Canada.