What are the responsibilities and job description for the Senior Manager, Regulatory Affairs position at EUSA Pharma?
Regulatory Affairs Lifecycle Management Specialist
Overview:
Manage RRD Regulatory Affairs Lifecycle Management for assigned products across multiple therapeutic areas for US and Canada, including contribution and implementation of the overall regulatory strategy, preparation of regulatory submissions and interface with relevant health authorities.
Key Responsibilities:
Requirements:
Work Environment:
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Based upon job requirements, employee may be required at times to attend meetings including travel out of state over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation. Employee is required to have a valid driver's license and means of transportation.
Overview:
Manage RRD Regulatory Affairs Lifecycle Management for assigned products across multiple therapeutic areas for US and Canada, including contribution and implementation of the overall regulatory strategy, preparation of regulatory submissions and interface with relevant health authorities.
Key Responsibilities:
- Provide input to the regulatory strategy for life cycle management in US and Canada.
- Implement regulatory strategies supporting lifecycle management for US and Canada.
- Review documentation and prepare lifecycle management submissions.
- Liaise with regulatory authorities as needed pertaining to product lifecycle management.
- Oversee submission of advertising and promotional material to the FDA as required.
- Support the labeling and/or change control processes to ensure timely and comprehensive review.
- Maintain labels/labeling for newly acquired and existing products in compliance with regulatory requirements and company standards.
- Track Annual Report and Periodic Safety Update Reports (PSUR) schedules to ensure that required dossiers are prepared and submitted as required.
- Coordinate with Medical Affairs & Pharmacovigilance to ensure timely reporting of safety data to regulatory agencies and partners.
- Ensure compliance with all federal regulations regarding post-marketing reporting to the FDA and other health authorities.
- Supervise and train direct reports as applicable.
- Act in full compliance with all laws, regulations, and policies including adverse events / pharmacovigilance responsibilities.
Requirements:
- Knowledge of current FDA and Health Canada regulations and guidances; and knowledge of and experience with pharmacovigilance and related drug safety reporting regulations.
- Ability to manage multiple priorities and regulatory submissions at different stages as required.
- Strong project management skills with proven ability to drive projects through to completion.
- Working knowledge of Veeva platform helpful but not required.
Work Environment:
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Based upon job requirements, employee may be required at times to attend meetings including travel out of state over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation. Employee is required to have a valid driver's license and means of transportation.
