Director of Regulatory Affairs #36990
Pharmaceutical
Menlo Park, CA Direct Hire Sep 13, 2024
Contemporary Staffing Solutions (CSS) is seeking a Director of Regulatory Affairs to join our client in Menlo Park, CA! The Director of Regulatory Affairs will develop and execute global regulatory strategies to ensure product market approval and maintain regulatory compliance. This position will manage key Quality Management System (QMS) processes and ensure adherence to applicable regulations (e.g., CLIA, CAP, State DOHs, FDA, ISO). This Direct-Hire opportunity offers a total compensation package of $350,000 per year, including a base pay range of $200,000-$225,000 per year.

Key Responsibilities:
  • Lead the development and implementation of global regulatory strategies aligned with business goals and applicable regulations.
  • Collaborate with cross-functional teams to ensure clear and strategic messaging in regulatory submissions and responses.
  • Manage risk assessments and mitigation strategies for products, ensuring that all relevant stakeholders are informed and aligned.
  • Analyze evolving legislation, regulations, and guidance, providing comprehensive insights to support decision-making for assigned products.
  • Present regulatory assessments and recommendations to senior management and ensure alignment with global strategies.
  • Serve as a key internal leader and driver of regulatory policy, strategy, and execution.
  • Interface with government regulatory agencies and ensure ongoing compliance across all operational activities.
  • Provide leadership and mentorship to the regulatory team, fostering professional growth and development.
  • Actively participate in relevant industry associations and trade groups to influence and align with regulatory trends.
  • Ensure that corporate objectives are met by making strategic decisions regarding work processes and operational plans.

Qualifications:
  • Bachelor’s degree in life sciences (biology, pharmacy, chemistry, pharmacology, or a related field).
  • Advanced degree or Regulatory Affairs Certification (RAC) preferred.
  • Minimum of 5 years of regulatory experience, with exposure to PMA regulatory work.
  • 3-5 years of leadership experience with proven management capabilities.
  • Experience interacting with regulatory agencies and health authorities.
  • Strong communication and analytical skills, with attention to detail and problem-solving abilities.
  • Ability to lead and drive results within set timelines and budget.
  • Experience managing remote teams and adapting to evolving business environments.
  • Comfortable with change management and fostering team motivation.
  • Willingness to travel (approximately 25%).

Contemporary Staffing Solutions (CSS) has been a leading provider of contract, temporary, temporary-hire & direct hire solutions. We began as a staffing agency and evolved to a national provider of workforce management solutions with a niche recruitment focus in Accounting & Finance, Call Center & Office, Human Resources, Sales & Marketing, & Information Technology. To learn more about CSS, visit our website: www.ContemporaryStaffing.com.