Senior Regulatory Affairs Associate - Operations

Jobs in Canada

Posted 4 weeks ago

Job title: Senior Regulatory Affairs Associate – Operations

Company: Haleon

Job description: *** Deadline to Apply: 23 February, 2025 ***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.Are you interested in a regulatory affairs role that allows you to accelerate regulatory compliance across the business? If so, this Senior Regulatory Affairs Associate – Operations position could be just what you’ve been looking for. Progress your career in regulatory affairs by working with a great team that is responsible for regulatory compliance locally. You’ll gain visibility into global Haleon processes and structures, collaborate with cross-functional and local teams, and gain a broad range of experiences with various team members.Job Purpose:As the Sr. Associate, Regulatory Affairs – RA Operations, reporting to the Regulatory Affairs Lead, you will be an integral part of the team in supporting local regulatory operations and compliance activities for Canada. In addition, you will advocate for best practices and continuous improvements, ensuring that this mindset is ingrained in our processes. You’ll be working on gaining efficiencies and maintaining regulatory compliance, always striving for excellence in our operations.Why Join Haleon?Competitive compensation and annual bonus package.Comprehensive and flexible benefits program from day 1.Defined contribution pension plan with employer matching.Optional Haleon Savings Plan with employer matching.We offer all new parents at Haleon 26 weeks of fully paid leave, regardless of gender or sexuality.Inclusive, diverse, and collaborative culture.Commitment to development and career progression.Hybrid model in a modern office located in Mississauga.Fitness centre, annual fitness subsidy, and bistro onsite.Key Responsibilities:This role will provide YOU with the opportunity to lead key activities to progress YOUR Regulatory Affairs career. These responsibilities include some of the following…Information management: Responsible for maintaining local compliance and accuracy of regulatory documentation systems (e.g. VEEVA). Resolve conflicts, ensure data integrity. Responsible for updates to other relevant global, regional and local databases to ensure compliance of product information. Prepare and maintain documentation for local listing of products (e.g. provincial schedule, formulary schedule)Operations support: Responsible for the preparation and assigning of product attributes of electronic documents for publishing to support regulatory submissions along with other required tasks. With oversight, prepares and complies regulatory submissions, responses to regulatory agency questions and other correspondence. Obtains copyright clearance.Manages local SOP and training programs.Supports compliance activities such as L1 monitoring, audit readiness/preparation and label compliance monitoring.Liase with QA, manufacturing sites and global CMC to obtain technical information to create change events in VEEVA.Develops and inputs into related processes to increase efficiencies for wider department.Performs related duties as assigned including preparation and filing of regulatory submissions, label development and artwork approvals.Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Post-secondary degree or relevant work experience.3 to 5 years of experience in Pharmaceutical/OTC field, working in Regulatory Affairs, Quality Assurance, or Compliance.Experience using Veeva RIMS or similar system.Ability to work independently while managing multiple workstreams.Preferred Qualifications:If you have the following characteristics, it would be a plus:Regulatory Affairs Certificate/Diploma preferred.Experience with change control, regulatory publishing and management monitoring activities preferred.Other relevant industry experience with database maintenance and compliance activities would be considered.Experience in the Consumer Healthcare industry preferred.#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.