Bilingual CMC Regulatory Affairs Manager (12 month contract)
Bilingual CMC Regulatory Affairs Manager (12 month contract)
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
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. Were Haleon. A new world-leading consumer health company. Shaped by all who join us. Together were improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands including Sensodyne Advil Voltaren Robax NeoCitran Buckleys Otrivin and Centrum through a unique combination of deep human understanding and trusted science. Whats more were achieving it in a company that were in control of. In an environment that were co-creating. And a culture thats uniquely ours. Care to join us. It isnt 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.
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 youve 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 Cte-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:
- Bachelors 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
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. Well provide all reasonable accommodations to support you throughout the recruitment process and treat all information you provide us in confidence.
Required Experience:
Manager
Employment Type
Full-Time
