Associate Director, Regulatory Affairs
Manage the regulatory activities ensuring that Company products comply and meet national and international regulatory requirements and standards.
- Develop and implement regulatory strategies pertaining to specific projects to expedite the development, filing, and regulatory approval for new and existing products.
- Manage directed regulatory projects.
- Represent Regulatory on assigned project teams, providing appropriate advice and support to ensure compliance with all regulatory requirements.
- Interact with regulatory authorities regarding assigned projects.
- Prepare and manage various submissions and correspondence to Regulatory authorities ensuring adherence to national and international regulations and standards (FDA, MDD, Health Canada, Latin America or Asia).
- Work with Technical Communications to publish and submit regulatory documents.
- Regularly interact with management regarding regulatory matters.
- Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies
- Review of labels, labeling, advertising and promotional materials for compliance with local and global regulations.
- May supervise and provide guidance to other personnel.
- Perform other related duties as required.
- BS or BA in life sciences or equivalent with 7 years experience in Regulatory Affairs in the medical device, pharmaceuticals and/or biotechnology industry. BLA and/or PMA submission to CBER experience highly desirable.
- Advanced knowledge and experience in interpretation of regulations and guidelines.
- Ability to demonstrate thorough knowledge of FDA requirements pertaining to submission of regulatory documents.
- Strong communication (oral and written); interpersonal and leadership skills
- Knowledge of QSR, and GMP requirements.
- Ability to determine the people, funding, materials and support to meet project and program goals and timelines.
- Excellent project management skills necessary to perform complex tasks independently and with the ability to adapt to changes easily.
- Must be able to work in a fast paced environment with demonstrated ability to effectively manage multiple competing tasks and demands.
- Ability to work independently, take initiative and complete tasks to deadlines.
Good organizational skills, self directed, and attentive to detail