Bilingual CMC Regulatory Affairs Manager (12 month contract)

Haleon; Montreal; Hybrid; CAD 80,000 - 110,000; Full time

Job summary

Join Haleon as a CMC Regulatory Affairs Manager to execute regulatory activities for product registrations and maintenance in the US and Canada. We value an inclusive culture and encourage applicants to navigate complex regulatory landscapes while contributing to daily health improvement for billions.

Benefits

Competitive compensation

Inclusive, diverse, and collaborative culture

Fitness centre/gym onsite

Career growth and internal advancement

Qualifications

• 5+ years’ experience in Regulatory Affairs, preferably in CPG/Consumer Healthcare/Pharma.
• Experience and knowledge in Quality, product development and manufacturing areas.

Responsibilities

• Lead preparation of CMC sections for new registration files and clinical trials applications.
• Interact with global functions to ensure regulatory compliance.
• Communicate regulatory technical requirements effectively.

Skills

Bilingualism (French and English)

Regulatory Affairs experience

Quality assurance knowledge

Product development knowledge

Manufacturing knowledge

Education

Bachelor's Degree in Life science/Pharmaceutically-related science

Job description

Please note: This position can be based out of Mississauga Ontario HQ, or our Manufacturing site in Ville St. Laurent, Quebec.

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 www.haleon.com/accessibility to learn more about our commitment to accessibility.

Do you want to be part of a growing and dynamic team in Haleon Canada? Are you someone who thrives on navigating complex regulatory landscapes and ensuring product compliance across US and Canadian markets? If so, the CMC Regulatory Affairs Manager role could be just what you’ve been looking for.

Job Purpose:

The purpose of this role is to execute CMC regulatory activities for new products registrations and life-cycle maintenance (including variations, annual reports and annual notifications) for the portfolio of products defined by the US and Canada Business Units.

Why Join Haleon?

• Competitive compensation
• Inclusive, diverse, and collaborative culture.
• Fitness centre/gym, bistro/cafeteria onsite.
• Commitment to development and career progression.
• Hybrid model either in a modern office located in Mississauga. Montreal site is steps from Côte-Vertu Metro.
• Career growth: Haleon promotes internal advancement
• Awork environment focused on development and employee well-being

Key Responsibilities:

This role will provide YOU with the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following…

• Preparation of CMC sections of new registration files (medicines, medical devices, cosmetics & foods), briefing books, clinical trials applications/INDs, CMC variations, and responses to Regulatory Agency technical questions.
• Interacts with colleagues in other global functions (e.g. Technical and Supply Chain) and Regulatory Affairs subfunctions (Category and LOCs) to deliver high-quality CMC sections for dossiers, including documents and materials to local Regulatory Affairs in accordance with business priorities. Ensures close partnership with authors, assuring technical congruency and regulatory compliance.
• Applies processes and procedures to maintain up-to-date technical product records/information and support adequate controls.
• Provides CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance, including completion of appropriate internal compliance records (e.g. change controls).
• Effectively communicates regulatory technical requirements and guidelines, facilitating timely and complete submissions. Develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends.

Basic Qualifications: .

We are looking for professionals with these required skills to achieve our goals:

• Bachelor's Degree in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
• Bilingualism Required - Due to the nature of the work tasks, applicants must be bilingual in French and English (written/spoken) to be considered, as in their role the incumbent must work closely with external/internal stakeholders in other provinces/countries that do not speak French.
• 5 + years’ experience in Regulatory Affairs, preferably within a CPG/Consumer Healthcare/Pharma related industry.
• Experience and knowledge in Quality, product development and manufacturing areas.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QP an asset but not required.

#LI-Onsite

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At 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 Requests

If 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.