Associate Director, Regulatory Affairs

2 weeks ago

Jersey City, New Jersey, United States Organon Full time

Job Description - Associate Principal Scientist

Company Overview: Organon

Organon is dedicated to providing innovative healthcare solutions that empower individuals to enhance their quality of life. As a global healthcare company with a $6.5 billion valuation, we are committed to addressing the unique needs of women, their families, and their communities. By investing in Women's Health, expanding biosimilar accessibility, and offering a diverse range of trusted health products, we strive to make each day healthier and better for every woman.

The Position

The role of Associate Principal Scientist involves developing and executing Regulatory Chemistry, Manufacturing, and Controls (CMC) strategies for specific small molecule products. Responsibilities include leading the preparation and submission of CMC dossiers for various regulatory purposes. Additionally, the role may entail overseeing a small team of contributors and collaborating on project goals and initiatives.

Key Responsibilities

  • Act as the CMC Product Lead for assigned products, ensuring the fulfillment of all regulatory milestones throughout the product life cycle.
  • Develop and implement global regulatory strategies for product and project needs, assessing CMC changes, regulatory requirements, and supporting documentation.
  • Lead the creation and review of CMC submission components for post-approval supplements, annual reports, and health authority inquiries.
  • Provide regulatory expertise for product licensing, divestment, and withdrawal processes.
  • Collaborate with internal and external partners to facilitate compliant change management and prioritize regulatory compliance.
  • Assess and mitigate regulatory risks while ensuring continuous product supply and approval.
  • Communicate potential regulatory issues to management and propose solutions to address them effectively.

Required Qualifications

  • Bachelor's degree in a relevant field with a minimum of seven years' experience, or an advanced degree with at least four years' experience in biological/pharmaceutical research, manufacturing, or testing.
  • Proficiency in negotiation, interpersonal communication, and written English.
  • Demonstrated ability to lead in complex organizational structures and manage projects effectively.
  • Strong analytical skills with a focus on change management projects.
  • Experience in reviewing scientific data critically and communicating complex issues clearly.
  • Proven track record of providing innovative solutions to regulatory challenges.
  • Effective leadership and team management skills to meet business objectives and timelines.

Preferred Qualifications

  • Degree in pharmacy, chemistry, or related disciplines.
  • Experience in Regulatory CMC post-approval lifecycle management.
  • Direct involvement in Regulatory CMC processes.

Join Our Team

Organon welcomes individuals who are passionate about making a difference in healthcare. If you are looking to contribute to meaningful projects and collaborate with a diverse team, consider applying for the Associate Principal Scientist position to drive innovation and regulatory excellence.

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