Job title: Regulatory Affairs Manager – Submission/Documentation (12-mo Contract)
Company: Haleon
Job description: Please make note of posting expiry date for application deadline.Internal Application Policy: You must notify your manager prior to applying for new roles.Please note: Visa sponsorship or relocation will not be offered for this position.Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Advil, Voltaren, Robax, NeoCitran, Buckley’s, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.We encourage applicants with accessibility needs to notify us if they have any accommodation needs during the application and/or interview process. Please visit to learn more about our commitment to accessibility.**12-month contract role**Are you interested in a regulatory affairs role that allows you to accelerate regulatory submissions and documentation across the business, while collaborating with local & global colleagues? If so, this Regulatory Affairs Manager – Submission/Documentation position could be an ideal opportunity to explore.Job Purpose:As the Regulatory Affairs Manager – Submission/Documentation, you will be responsible for supporting the Regulatory brand managers in the preparation and filing of formulation initiatives, including documentation sourcing, CMC documentation preparation and artwork review.Why Join Haleon?Inclusive, diverse, and collaborative culture.Commitment to development and career progression.Hybrid model in a modern office located in Mississauga.Fitness centre and bistro onsite.Key Responsibilities:This role will provide YOU with the opportunity to lead key activities to progress YOUR Regulatory Affairs career. The successful candidate will manage the following key responsibilities:Prepare and compile regulatory submissions including formulation/source documentation review, maintaining regulatory documentation systems (VEEVA RIMS) and responding to regulatory agency questions.Collaborate with Global and local stakeholders (commercial, Global Reg, R&D, etc.) to obtain appropriate documentation and manage critical timelines to ensure overall project delivery.Generate relevant Chemistry and Manufacturing documentation required for submission and to maintain internal requirements.Create label text, manage and approve artwork in line with Health Canada Requirements.Support Research & Development in documentation collection and storage.Perform related duties as assigned to support the Regulatory Affairs team with other related regulatory activities as assigned.Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Post-secondary degree or relevant work experience3-5 years of pharmaceutical/OTC industry experience in Regulatory Affairs3-5 years of experience with submissions and negotiations with Health CanadaKnowledge of submission requirements and timelinesAbility to work independently while managing multiple workstreamsPreferred Qualifications:If you have the following characteristics, it would be a plus:Bachelor’s in science or related fieldPost-graduate Regulatory Affairs Certificate/Diploma3-5 years’ experience in OTC or Consumer Healthcare#LI-HybridCare to join us. Find out what life at Haleon is really likeAt Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.Accommodation RequestsIf you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process, please let your recruiter know by providing them with a description of specific accommodations you are requesting. We’ll provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence.
Expected salary:
Location: Mississauga, ON
Job date: Sat, 15 Feb 2025 04:05:54 GMT
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