Posted: 12 September
Offer description
Regulatory Affairs Specialist
This is a contract position that offers full benefits. We are seeking a Regulatory Affairs Specialist to join our team.
Job Description:
* Evaluate regulatory data to support the development of local, regional, and global regulatory strategies.
* Participate in advocacy activities of a technical and/or tactical nature.
* Analyze the regulatory environment and provide internal guidance throughout the product lifecycle to ensure product compliance.
* Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.).
* Support the development of regulatory strategy and update strategy based upon regulatory changes.
* Evaluate proposed products for regulatory classification and jurisdiction.
* Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
* Provide regulatory information and guidance for product development and planning throughout the product lifecycle to regulatory teams and others within the organization.
* Compare regulatory outcomes with initial product concepts and recommend changes or refinements based on initial regulatory outcomes.
* Negotiate with regulatory authorities throughout the product lifecycle.
* Identify the need for new regulatory procedures, SOPs, and participate in development and implementation.
* Train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
* Assist other departments in the development of SOPs to ensure regulatory compliance.
* Provide regulatory input and technical guidance on global regulatory requirements to product development teams.
* Advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
* Assess the acceptability of quality, preclinical, and clinical documents for submission filing to comply with applicable regulations.
* Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategize (if appropriate) for changes that do not require submissions.
* Provide knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships.
* Identify, monitor, and submit applicable reports or notifications to regulatory authorities during the clinical research process.
* Provide regulatory information and guidance for proposed product claims/labeling.
* Ensure that clinical and non-clinical data, in conjunction with regulatory strategy, are consistent with regulatory requirements and support proposed product claims.
* Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
* Monitor the progress of regulatory authority review processes through appropriate communications with the agency.
* Communicate and interact with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
* Collaborate with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.
