Sr. Manager/Associate Director, Regulatory Affairs

Hybrid (50/50)

Morristown, NJ 07960

2321

JGOODMAN

Our client is seeking a Senior Manager/Associate Director of Regulatory. The position will be responsible for coordinating and ensuring quality regulatory submissions for the company. This is an opportunity for an experienced individual to join a growing specialty pharmaceutical company and work directly with senior management.

The successful candidate will:

  • Lead and manage a team of Regulatory Affairs professionals.
  • Coordinate and review all regulatory submissions of the company including ANDAs and 505(b)(2) NDAs, as needed.
  • Develop and implement regulatory strategies and filings throughout each product’s lifecycle.
  • Manage regulatory risks and ensure compliance with all applicable regulations.
  • Ensure regulatory and cross-functional project strategies and submission timelines are in alignment for successful filing and timely approval.
  • Actively monitor changes in applicable regulatory requirements and industry trends, and proactively identify and propose solutions for potential regulatory challenges.
  • Maintain drug product labeling components for all commercial products.
  • Author and review departmental SOPs, as well as any other additional SOPs that may impact regulatory affairs.

Qualifications:

  • Bachelor’s degree in a scientific or technical field (e.g., chemistry, biology, pharmaceutics, etc.)
  • 7+ years of work experience in US FDA regulated pharmaceutical development and manufacturing, including making submissions in eCTD format.
  • A degree in regulatory affairs is preferred.
  • Strong background in CMC documentation preferred.
  • Must demonstrate strong leadership qualities: strategic thinking, decision making, problem solving, communication skills, attention to detail, project management, team building and development, professional integrity, influence and negotiating skills, adaptability and flexibility, and stakeholder management.
  • Excellent organizational and time management.
  • Exceptional communication and interpersonal skills across all levels of the Company.
  • Self-starter who can be effective with minimal supervision.
  • Excellent writing and communication skills consistent with the ability to prepare concise, timely, and accurate reports/presentations.
  • Previous experience in managing personnel is a plus.