Senior Regulatory Affairs Specialist

Responsibilities and capabilities:

Support Product Development & Registration:

• 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 documentation for submission filing to comply with applicable regulations.
• Evaluates proposed preclinical, clinical and manufacturing changes for regulatory filing solutions and proposes plans/strategizes 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 (e.g., Serious Adverse Events) or notifications (e.g., changes in manufacturing) 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.
• 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.

SupportPost-approval/Post-marketActivities:

• Develops and implements processes involved with maintaining annual licenses, registrations and listings.
• Reviews and approves advertising and promotion to ensure regulatory compliance.
• Assures post-market regulatory requirements are met (e.g., required reports, supplemental submissions and other post-marketing commitments.)
• Submits notifiable changes and supplemental dossiers to the appropriate regulatory authorities to update product information and/or instructions for use to reflect current state of product knowledge.
• Participates in implementation of regulatory strategy and processes for handling recalls and communication to stakeholders (e.g., Dear Healthcare Professional letters, patient letters, distributor letters, and health authorities).
• Reports product safety issues and reportable events to regulatory authorities as required, to comply with local, regional and global regulations.
• Provides required information (e.g., clinical data) in support of product reimbursement requests.
• Provides regulatory input and appropriate follow-up for inspections and audits.

Conduct Regulatory Surveillance and Develop Regulatory Strategies

• 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 and distribution (federal, provincial/territorial state, reimbursement, purchasing groups, HTA, 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 submissions, approval pathways and compliance activities.
• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory unit and other units in the organization.
• Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes.
• Identifies the need for new regulatory procedures and 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.