Director/Senior Director, Regulatory Affairs

Alternative Resources Company

Director/Senior Director, Regulatory Affairs

Director/Senior Director, Regulatory Affairs
 
Reporting to the President, the Director/Senior Director of Regulatory Affairs leads the regulatory function for the company, key activities include leading and managing the Regulatory Affairs team, strategy and submissions to regulatory authorities (i.e., ANDAs, supplements, amendments, etc.), reporting and liaising with regulatory authorities.  The Director/Senior Director of Regulatory Affairs is accountable for ensuring that regulatory submissions are high quality, approvable, consistent and completed within defined timelines and budget. 
 
Responsibilities
  • Oversees and directs a regulatory affairs team to ensure end-to-end regulatory strategy development and regulatory affairs activities lead to desired results for the company’s pipeline and marketed pharmaceutical portfolio
  • Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure attainment of regulatory authority approval
  • Owns the preparation of ANDA submissions to regulatory authorities which includes planning, writing and reviewing
  • Reviews and provides guidance on advertising and promotional practices, product labeling and corporate communications and training
  • Communicates with and builds relationships with regulatory agencies through strategy alignment and interactive submissions
  • Ensures that internal regulatory policies, procedures and practices comply with appropriate regulatory requirements
  • Provides robust regulatory guidance and recommendations to cross-functional partners
  • Identifies, prioritizes, allocates and manages appropriate resources to successfully achieve strategic objectives and maintain compliance
  • Conducts regulatory due diligence for business development opportunities
  • Provides leadership, personnel development, training, coaching and mentoring for staff
 
Qualifications
  • Bachelor’s degree in life sciences or related discipline, Master’s/Advanced degree is preferred
  • 10+ years of progressive regulatory experience within the Generic industry working across a variety of delivery systems and dosage forms including injectables and solid dosage products.
  • Demonstrated successful leadership experience is required
  • A proven track record of ANDA approvals
  • Expert knowledge of FDA regulations, policies and procedures, guidance documents for generic drugs and current Good Manufacturing Practices (cGMP)
  • Excellent verbal and written communication skills, including the ability to present and train effectively
  • Balance critical thinking and strong analytical skills with ability to execute
  • Knowledgeable about the drug development process for contract manufacturing organizations
  • Big picture focused yet able to master the details
  • Ability to work in a small, non-bureaucratic company where entrepreneurial spirit and accountability are highly valued
  • Willingness to roll-up sleeves and approach the position in a hands-on manner
  • Willingness to travel domestically and internationally on an as needed basis once travel restrictions are lifted