Work Flexibility: Hybrid or Onsite
(23 month fixed term contract)
Key Areas of Responsibility:
- Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
- Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
- Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
- Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
- Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
- Evaluates proposed products for regulatory classification and jurisdiction
- Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
- Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
- Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
- Negotiates with regulatory authorities throughout the product lifecycle
- Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
- Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
- Assists other departments in the development of SOPs to ensure regulatory compliance
- Provides regulatory input and technical guidance on global regulatory requirements to product development teams
- Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
- Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
- Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
- Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
- Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
- Provides regulatory information and guidance for proposed product claims/labeling
- Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
- Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
- Monitors the progress of the regulatory authority review process through appropriate communications with the agency
- Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
- Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees
Education / Work Experience:
- BS in Engineering, Science, or related degree; or MS in Regulatory Science
- Typically a minimum of 2 years’ experience
- MS or RAC(s) preferred
Knowledge / Competencies:
- Project management, writing, coordination, and execution of regulatory items
- Perform technical and scientific regulatory activities
- Usually works with minimum supervision, conferring with superior on unusual matters
- Assignments are broad in nature, requiring originality and ingenuity
- Has some latitude for unreviewed action or decision
#IJ
Travel Percentage: None
