- Directs and influences the preparation of documentation to support high quality regulatory submission dossiers.
- Engages with global international regulatory partners to support regulatory strategy for new products/therapies and changes to existing products. Partners with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
- Engages with global regulatory agencies representing the company and ensuring the voice of the regulator is considered in developing global regulatory strategies.
- Leads regulatory filings to support submissions, license renewal and annual registrations.
- Influences clinical evidence strategy to support labeling content, marketing claims and regulatory compliance.
- Support manufacturing strategy via a robust change control approach to ensure global approval and implementation of product and process changes
- Mentors and coaches’ other employees within the department and provides leadership support to ensure strong talent development.
- Keeps abreast of regulatory procedures and changes. Supports industry advocacy activity to shape the future of evolving regulatory requirements. Develops internal procedures to ensure continuous compliance with all regulatory requirements.
- Develops strategies for earliest possible global approvals of regulatory filings.
- Supports regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
- Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives.
- Level 8 Bachelor’s Degree/Masters or equivalent in Science, Engineering or related discipline.
- Regulatory experience in Medical Devices and or Pharmaceuticals is desirable, however, candidates with a minimum of 6 year’s relevant experience will also be considered.
- Recognized expert, capable of managing large projects or processes.
- Dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
- Strong technical knowledge. You are skilled in thinking critically and making sound decisions.
- Collaborate with others and create alignment with team members, at times acting as a team leader.
- You are a strong coach/mentor and can provide coaching/training to other employees within the RA Department.
- You set high standards and drive accountability in the execution of your responsibilities and you model ethical behavior.
- Good communicator and fluent in English, both in writing and speaking with strong organizational skills.
Or call Megan Warr on 091507515 for a confidential conversation