Regulatory Submission Expert

7 days ago

Québec, Quebec, Canada Syneos Health Full time

Job Description

The Clinical Activation Specialist is responsible for one or more of the following functions at the country level:

  • Local Submissions Specialist: Follows project direction provided by the designated country start-up advisor (CSA) and SAL. May serve as a point of contact for the SAL/PM (or designee) during start-up on allocated projects.
  • Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision.
  • May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversees site activation end-to-end process at country/site level.
  • Local Site ID and Feasibility Support: Provides support with site selection lead and PM/SAL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
  • Local Investigator Contract and Budget Negotiator: Supports the SAL to agree on country template contract and budget. Assists in producing site-specific contracts from country template. Under supervision, assists in negotiations of budget and contract with site and via Site Contracts Service Centre and SAL lead with Sponsor until resolution of issues and contract execution.

  • CMC Submission Expert

    2 hours ago

    Québec, Quebec, Canada Syneos Health Full time

    **Key Responsibilities**- Execute commercial LCM strategy and submissions reviews- Work with regulatory colleagues in development of global regulatory CMC strategies and Submissions- Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies-

  • Regulatory Strategy Lead

    2 hours ago

    Québec, Quebec, Canada Syneos Health Full time

    Job SummaryYou will be responsible for the development of regulatory submissions and post marketing regulatory support for clients. This includes authorship of portions of regulatory submissions, regulatory writing, regulatory research, and ensuring compliance with relevant guidelines and standards.You will provide advice and assistance to clients and other...

  • Regulatory Affairs Director

    10 hours ago

    Québec, Quebec, Canada Syneos Health Full time

    At Syneos Health, we accelerate customer success by translating unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities. Our Clinical Development model puts the customer and patient at the center of everything we do. We are always looking for ways to simplify and streamline our work to make Syneos Health...

  • Regulatory Consultant

    2 weeks ago

    Québec, Quebec, Canada Syneos Health Full time

    Description Regulatory Consultant (CMC experience within LATAM or APAC region required) Syneos 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. Our Clinical Development...

  • Sr. Regulatory Consultant

    1 week ago

    Québec, Quebec, Canada Syneos Health Full time

    Sr. Regulatory Consultant - Canada Syneos 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. Our Clinical Development model brings the customer and the patient to the center...

  • Sr. Regulatory Consultant

    11 hours ago

    Québec, Quebec, Canada Syneos Health Full time

    Description Sr. Regulatory Consultant - Canada Syneos 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. Our Clinical Development model brings the customer and the patient to...

  • Senior Regulatory Specialist

    7 days ago

    Québec, Quebec, Canada Syneos Health Full time

    Company OverviewSyneos Health is a leading fully integrated biopharmaceutical solutions organization. Our mission is to accelerate customer success by translating unique clinical, medical affairs and commercial insights into outcomes that address modern market realities.About the RoleThis is an exciting opportunity for a Sr Regulatory Consultant to join our...

  • Sr. Regulatory Consultant

    7 days ago

    Québec, Quebec, Canada Syneos Health Full time

    Description Sr. Regulatory Consultant - Canada Syneos 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. Our Clinical Development model brings the customer and the...

  • Sr. Regulatory Consultant

    3 days ago

    Québec, Quebec, Canada Syneos Health Full time

    Description Sr. Regulatory Consultant - Canada Syneos 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. Our Clinical Development model brings the customer and the patient...

  • Sr Regulatory Consultant

    1 week ago

    Québec, Quebec, Canada Syneos Health Full time

    Senior Regulatory Consultant Syneos 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. Our Clinical Development model brings the customer and the patient to the center of...

  • Sr Regulatory Consultant

    11 hours ago

    Québec, Quebec, Canada Syneos Health Full time

    Description Senior Regulatory Consultant Syneos 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. Our Clinical Development model brings the customer and the patient to the...

  • Regulatory Expertise Leader

    7 days ago

    Québec, Quebec, Canada Syneos Health Full time

    Job ResponsibilitiesThe successful candidate will be responsible for executing commercial Lifecycle Management (LCM) strategy and submissions, reviewing CMC sections of regulatory submissions, working with regulatory colleagues to develop global regulatory CMC strategies and submissions, managing day-to-day regulatory activities for assigned projects, and...

  • Sr Regulatory Consultant

    1 week ago

    Québec, Quebec, Canada Syneos Health Full time

    Regulatory Affairs Associate Director Syneos 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. Our Clinical Development model brings the customer and the patient to the...

  • Sr Regulatory Consultant

    11 hours ago

    Québec, Quebec, Canada Syneos Health Full time

    Description Regulatory Affairs Associate Director Syneos 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. Our Clinical Development model brings the customer and the patient...

  • Regulatory Consultant Specialist

    7 days ago

    Québec, Quebec, Canada Syneos Health Full time

    Company OverviewSyneos Health is a leading, fully integrated biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.Job DescriptionWe are seeking an experienced Regulatory Consultant Specialist to join our team in...

  • Regulatory CMC Consultant

    6 hours ago

    Québec, Quebec, Canada Syneos Health Full time

    **Your Role**We are seeking an experienced Regulatory CMC Consultant to join our team. In this role, you will be responsible for executing commercial Lifecycle Management (LCM) strategy and submissions reviews. You will work with regulatory colleagues to develop global regulatory CMC strategies and submissions.

  • Sr Regulatory Consultant

    3 weeks ago

    Québec, Quebec, Canada Syneos Health Full time

    Description Senior Regulatory Consultant Syneos 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. Our Clinical Development model brings the customer and the patient to the...

  • Sr Regulatory Consultant

    7 days ago

    Québec, Quebec, Canada Syneos Health Full time

    Description Senior Regulatory Consultant Syneos 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. Our Clinical Development model brings the customer and the patient to...

  • Sr Regulatory Consultant

    2 weeks ago

    Québec, Quebec, Canada Syneos Health Full time

    Description Regulatory Affairs Associate Director Syneos 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. Our Clinical Development model brings the customer and the...

  • Sr Regulatory Consultant

    7 days ago

    Québec, Quebec, Canada Syneos Health Full time

    Description Regulatory Affairs Associate Director Syneos 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. Our Clinical Development model brings the customer and the...