Associate Director, Regulatory Affairs

Location
94520, Concord
Posted
Jun 29, 2018
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Manage the regulatory activities ensuring that Company products comply and meet national and international regulatory requirements and standards.

Primary Responsibilities:

  1. Develop and implement regulatory strategies pertaining to specific projects to expedite the development, filing, and regulatory approval for new and existing products.
  2. Manage directed regulatory projects.
  3. Represent Regulatory on assigned project teams, providing appropriate advice and support to ensure compliance with all regulatory requirements.
  4. Interact with regulatory authorities regarding assigned projects.
  5. 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).
  6. Work with Technical Communications to publish and submit regulatory documents.
  7. Regularly interact with management regarding regulatory matters.
  8. Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies
  9. Review of labels, labeling, advertising and promotional materials for compliance with local and global regulations.
  10. May supervise and provide guidance to other personnel.
  11. Perform other related duties as required.

    Qualifications/Requirements/Skills: 

  • 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.
  1. 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