Senior Regulatory Affairs Specialist

1 month ago


Québec, Quebec, Canada Parexel Full time
Join Our Team as a Senior Regulatory Affairs Consultant

About the Role

We are seeking a highly skilled Senior Regulatory Affairs Consultant to join our team at Parexel. As a key member of our regulatory affairs department, you will play a critical role in ensuring the compliance of our clients' products with global regulatory requirements.

Key Responsibilities

  • Develop and implement CMC regulatory strategies for investigational and marketed biologic and small molecule drug products.
  • Provide regulatory guidance and support to cross-functional teams, including manufacturing and quality groups.
  • Prepare and review CMC and GMP-related documents for submission to regulatory authorities.
  • Collaborate with global functional units and external partners to ensure compliance with regulatory requirements.
  • Participate in Health Authority CMC meeting preparations and rehearsals.

Requirements

  • 7+ years of CMC regulatory experience in the pharmaceutical industry.
  • Proven track record of experience with biologic submissions, small molecule experience highly preferred.
  • Comprehensive knowledge of drug development process, pharmaceutical technology, and GMP-related issues.
  • Strong analytical, problem-solving, organizational, and negotiation skills.
  • Ability to work in a matrixed environment and across cultural lines.

What We Offer

Parexel is an equal opportunity employer. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.



  • Québec, Quebec, Canada Innomar Strategies Full time

    At Innomar Strategies, we're united in our responsibility to create healthier futures. Our team members are at the heart of everything we do, and every person here is essential to delivering on that purpose.Job SummaryWe're seeking a highly skilled Regulatory Affairs Specialist to join our innovative company. As a key member of our team, you'll play a...


  • Québec, Quebec, Canada Innomar Strategies Full time

    At Innomar Strategies, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for coordinating and compiling regulatory submissions, responses to agency questions, and other correspondence in accordance with requirements for assigned projects. You will apply your...


  • Québec, Quebec, Canada beBee Professionals Full time

    Job Overview:We are looking for a Regulatory Affairs Specialist - Pharmaceuticals to join our team at beBee Professionals. The successful candidate will be responsible for providing regulatory expertise and support to our pharmaceuticals division. The ideal candidate will have a strong understanding of the regulatory framework and a minimum of 5 years of...


  • Québec, Quebec, Canada Parexel Full time

    Lead Regulatory Affairs TeamParexel is seeking a seasoned Regulatory Affairs Director to lead our Regulatory Affairs team. As a key member of our leadership team, you will be responsible for providing strategic guidance and technical expertise to drive regulatory success.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance...


  • Québec, Quebec, Canada Parexel Full time

    Lead Regulatory Affairs TeamParexel is seeking a seasoned Regulatory Affairs Director to lead our Regulatory Affairs team. As a key member of our leadership team, you will be responsible for providing strategic guidance and technical expertise to drive regulatory success.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance...


  • Québec, Quebec, Canada Parexel Full time

    Lead Regulatory Affairs ExpertParexel is seeking a seasoned Regulatory Affairs professional to lead our team and drive strategic growth in the life sciences industry.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance and drive business growthLead a high-performing team of Regulatory Affairs professionals and provide...


  • Québec, Quebec, Canada Parexel Full time

    Lead Regulatory Affairs ExpertParexel is seeking a seasoned Regulatory Affairs professional to lead our team and drive strategic growth in the life sciences industry.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance and drive business growthLead a high-performing team of Regulatory Affairs professionals and provide...


  • Québec, Quebec, Canada Parexel Full time

    Lead Regulatory Affairs ExpertParexel is seeking a seasoned Regulatory Affairs Director to join our team. As a key member of our organization, you will be responsible for leading and mentoring a team of high-performing Regulatory Affairs professionals, providing strategic, technical, and regulatory advice to clients, and managing client relationships.Key...


  • Québec, Quebec, Canada Parexel Full time

    Lead Regulatory Affairs ExpertParexel is seeking a seasoned Regulatory Affairs Director to join our team. As a key member of our organization, you will be responsible for leading and mentoring a team of high-performing Regulatory Affairs professionals, providing strategic, technical, and regulatory advice to clients, and managing client relationships.Key...


  • Québec, Quebec, Canada Syneos Health Full time

    Regulatory Affairs Associate DirectorSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Key Responsibilities:Develop and implement regulatory strategies to ensure...


  • Québec, Quebec, Canada Syneos Health Full time

    Regulatory Affairs Associate DirectorSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Key Responsibilities:Develop and implement regulatory strategies to ensure...


  • Québec, Quebec, Canada Syneos Health Full time

    Job Title: Associate Director, Regulatory AffairsAt Syneos Health, we are seeking an experienced Associate Director, Regulatory Affairs to join our team. As a key member of our regulatory department, you will be responsible for contributing to the planning and execution of regulatory submissions in assigned regions/countries/projects.Key...


  • Québec, Quebec, Canada Syneos Health Full time

    Job Title: Associate Director, Regulatory AffairsAt Syneos Health, we are seeking an experienced Associate Director, Regulatory Affairs to join our team. As a key member of our regulatory department, you will be responsible for contributing to the planning and execution of regulatory submissions in assigned regions/countries/projects.Key...


  • Québec, Quebec, Canada Syneos Health Full time

    Unlock New Opportunities in Regulatory AffairsJoin Syneos Health, a leading biopharmaceutical solutions organization, as a Regulatory Affairs Director of Strategic Development. As a key member of our team, you will play a vital role in shaping the future of regulatory strategy and driving business growth. This exciting opportunity offers a unique chance to...


  • Québec, Quebec, Canada beBee Professionals Full time

    Job Title: Regulatory Affairs and Compliance ExpertbeBee Professionals is seeking an experienced Regulatory Affairs and Compliance Expert to join our team in Quebec City. The successful candidate will be responsible for ensuring the company's compliance with environmental, health, and safety regulations.The ideal candidate should have a degree in...


  • Québec, Quebec, Canada Syneos Health Full time

    About the RoleSyneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.As a Site Start-Up & Regulatory Specialist II, you will play a critical role in ensuring the quality of our clinical...


  • Québec, Quebec, Canada Syneos Health Full time

    About the RoleSyneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.As a Site Start-Up & Regulatory Specialist II, you will play a critical role in ensuring the quality of our clinical...


  • Québec, Quebec, Canada Syneos Health Full time

    About the RoleWe are seeking an experienced Regulatory Affairs Associate Director to join our team at Syneos Health. As a key member of our regulatory team, you will be responsible for contributing to the planning and execution of regulatory submissions in assigned regions/countries/projects.Key ResponsibilitiesContribute to the preparation of regulatory...


  • Québec, Quebec, Canada Syneos Health Full time

    About the RoleWe are seeking an experienced Regulatory Affairs Associate Director to join our team at Syneos Health. As a key member of our regulatory team, you will be responsible for contributing to the planning and execution of regulatory submissions in assigned regions/countries/projects.Key ResponsibilitiesContribute to the preparation of regulatory...

  • Site Start-Up

    1 week ago


    Québec, Quebec, Canada Syneos Health Full time

    Job Title: Site Start-Up & Regulatory Specialist IIAbout the Role:We are seeking a highly skilled Site Start-Up & Regulatory Specialist II to join our team at Syneos Health.Key Responsibilities:- Collaborate with cross-functional teams to ensure regulatory compliance- Develop and implement site start-up strategies- Provide regulatory guidance and...