Senior Regulatory Affairs Associate

Posted 01 Feb 2024

Mississauga, Ontario - Canada

Req Id 271618

 

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

 


Your Role:

The Senior Regulatory Affairs Associate is responsible for the planning, submission and management of regulatory activities for lifecycle and strategic products. This role involves participation in the development and implementation of regulatory strategies.

General Responsibilities:

  • Strong submission planning to enable efficient and timely dossier preparation and submission for pre- and post-market dossiers across therapeutic areas.
  • Contribute to regulatory strategy development and execute regulatory activities with guidance for products in accordance with corporate priorities
  • Maintain registration compliance for approved products to support the ongoing marketing in Canada
  • Represent the Regulatory Affairs function in actively contributing to cross-functional teams and initiatives. Build and maintain positive and productive relationships with internal interfaces
  • Responsible for the modification/creation and maintenance of product labeling
  • Responsible for managing communication/responses to Health Canada for submissions including coordination across stakeholders with guidance from management
  • Participate in regulatory strategic teams

Specific Responsibilities:

  • Provide regulatory and scientific assessment of and perform regulatory affairs activities associated with the development of investigational drugs, medical devices, labelling/CMC changes in assigned Therapeutic Areas.
  • Responsible for the guided preparation of submissions including post-approval (NOC), medical device licenses, and NDS support as required. Assist in Pre-submission meetings with Health Canada
  • Ensure compliance with local regulations and compatibility with Corporate business needs
  • Fully responsible for the creation/modification and maintenance of product packaging artwork and Product Monographs to ensure compliance with the Canadian Food and Drugs Act, regulations and internal standards.
  • Contribute to regulatory strategy development and communicate regulatory advice for Canadian regulatory requirements and functional support
  • Review and approve promotional materials
  • Maintain document management for all Regulatory files and correspondence within regulatory systems (e.g. Veeva)
  • Contribute to the improvement and generation of regulatory working instructions/flow processes/procedures including implementation of new requirements
  • Review and execute change control procedures that are performed at the local level
  • All other duties as assigned

 

Position located onsite in Mississauga, Ontario

 

Who you are:

Minimum Qualifications:

  • 3+ years of experience in Canadian Regulatory Affairs role in the biotechnology or pharmaceutical industry
  • Bachelor’s degree in a Life Science or a similar scientific discipline.

Preferred Qualifications:

  • Advanced degree and post-graduate regulatory affairs certification are assets.
  • Excellent communication skills, including written & verbal
  • Strong organizational and project management skills including the ability to manage multiple projects and priorities effectively
  • Demonstrated knowledge of the Canadian Food and Drugs Act and Regulations and relevant Health Canada policies and guidance documents
  • Solid understanding of product development, including pharmacology, toxicology, pharmacokinetics and clinical studies
  • Strong analytical skills with the ability to assess scientific data
  • Demonstrated interpersonal skills with respect to relationship building and teamwork
  • Proficiency with Microsoft Office (Word, Excel, PowerPoint) and Adobe
  • Travel up to 10%

 



What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html


US Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.


North America Disclosure

If you are a resident of California, Colorado, New York, or Washington, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.


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