Job Description

In this exciting and fast-paced role, the candidate will exercise their regulatory affairs expertise and project management and senior leadership talents, working with our broader team of experienced regulatory affairs and toxicology experts, and use their industry contacts to grow and expand our consulting services. The Senior Manager II, 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 U.S. FDA and Health Canada regulatory requirements, 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. Experience in a breadth of projects at different stages of development will be critical, as well as relevant, direct experience in development programs for a variety of product types. As the Senior Manager II, Regulatory Affairs, you will work with other in-house professionals on the day- to-day tasks associated with regulatory affairs and provide hands on leadership to the regulatory affairs team in the preparation of U.S and Canadian regulatory submissions and providing advice on impact of ongoing changesin regulatory and compliance policies and procedures. The Senior Manager II, Regulatory Affairs will directly engage with and support Intertek\xe2\x80\x99s clients, serving as a representative of the consultancy and as a subject matter expert for the company.

Responsibilities:

• As a senior regulatory affairs expert, provide strategic advice and leadership to advance development of products and ensure efficient progress from research to First-in-Human, Proof of Concept and Pivotal Studies through to marketing. Provide advice on product development plans, conduct gap analyses, and develop and implement detailed strategies. Keep abreast of relevant regulatory changes and inform team, if and as necessary.
• Manage and coordinate Regulatory Agency negotiations and meetings, e.g., FDA, Health Canada. Address questions from and facilitate meetings or liaise with regulatory agencies on behalf of clients.
• Lead and guide the writing and/or review of regulatory strategy documents, gap assessments, regulatory agency meeting materials, designation requests, etc. across a breadth of products.
• Actively participate in the preparation of regulatory submissions and oversee operational regulatory activities necessary to the project and client success. Write, manage, review, and prepare all types of global dossiers for regulatory submissions in the U.S. and Canada for pharmaceuticals and biologics products, e.g., pre-submission meeting materials, IND/CTA, NDS/NDA/BLA, supplements, amendments, notifications, DMFs, etc.
• Be a senior consultant, able to identify and generate new business and actively market Intertek\xe2\x80\x99s 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 clients and companies in the global pharmaceutical and 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.

Desired Qualifications and Experience:

Undergraduate Degree, MSc/M.S., PhD in a relevant field; 8+ years of regulatory experience in an industry setting. RAC certification preferred.

• Consulting experience preferred.
• Subject matter expert: Leader in the regulatory affairs field with developed acumen in relevant areas, including knowledge of product development, up-to-date regulatory 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.

Personal Characteristics:

• Excellent communication skills in both verbal and written format; able to develop persuasive, clear arguments and rationales.
• Good technical writing skills and the ability to review and critique safety, efficacy, and quality submission documents.
• Enjoys the challenge of analyzing and solving problems.
• Excellent interpersonal skills and organizational, time management, and communication and interaction skills are essential 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.

Our Value Proposition

We offer a salary and benefits package competitively placed within the local market, including medical, dental, vision, life, disability, RRSP with company match, generous vacation/sick time (PTO), tuition reimbursement and more.

Why Work at Intertek?

Intertek is a world leader in the $250 billion Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. At Intertek, we exercise our spirit of innovation, the passion of our people and our unmatched customer commitment to realize our purpose of making the world an ever better, safer, and more sustainable place for all. Learn more about Our History and What We Do.

A career with Intertek offers rewarding opportunities to help companies around the world develop products used safely by millions of people every day. Intertek is the trusted advisor to many of the world\xe2\x80\x99s leading brands, companies, and governments, and has earned a reputation for accuracy, reliability, integrity, and technical competence. Working at Intertek means joining a global network of state-of-the-art facilities and passionate people who deliver superior customer service with a purpose of bringing quality, safety, and sustainability to life.

Intertek is committed to a safe work environment for our employees and clients. Learn more about our COVID-19 Policy.

Intertek believes that Our People are our strongest tool for success. We are an Equal Opportunity Employer and do not discriminate against applicants due to veteran status or on the basis of disability. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, or gender identity

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