CMC Strategy Expert

7 days ago

Jersey City, New Jersey, United States Organon Full time

About the Role

Organon is seeking a highly skilled and experienced professional to join our Regulatory Affairs team as an Associate Principal Scientist. This role will be responsible for leading the development and execution of regulatory chemistry, manufacturing, and controls (CMC) strategies to ensure high-quality, accurate, and timely regulatory submissions.

Key Responsibilities

  • Partner with cross-functional teams, including Research and Development, Manufacturing and Supply, Business Development, and Commercial, to develop and implement CMC strategies and execute clinical study phase and initial product registration activities.
  • Provide regulatory CMC expertise and oversight in developing global CMC strategies and executing submissions related to late-stage development and licensed-in products.
  • Lead the development and execution of regulatory CMC strategies to ensure high-quality, accurate, and timely regulatory submissions.
  • Embed regulatory CMC activities within product development plans, outlining requirements, development plans, and associated regulatory approval timelines.
  • Ensure regulatory requirements are met and systems/processes are executed to provide visibility to accurate regulatory information, enabling proper product control.
  • Identify, communicate, and escalate potential regulatory issues to Organon Regulatory CMC management, as needed.

Requirements

  • Bachelor's degree in a science, engineering, or related field, with at least 7 years of relevant experience, including biological/pharmaceutical research, manufacturing, testing, or a related field.
  • Advanced degree (MS, MBA, Ph.D., PharmD) with at least 4 years of relevant experience, including biological/pharmaceutical research, manufacturing, testing, or a related field.
  • Direct experience in Regulatory CMC is preferred.
  • At least 5 years of relevant experience, including biological/pharmaceutical research, manufacturing, analytical testing, or related fields.
  • Proficient in English; additional language skills are a plus.
  • Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale.
  • Demonstrated superior oral and written communication skills in multicultural settings.
  • Demonstrated sound understanding of related fields and ability to be creative and imaginative in problem-solving.
  • Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
  • Demonstrated effective leadership, communication, interpersonal, and negotiating skills.

Preferred Experience and Skills

  • A candidate with experience in Regulatory CMC, with demonstrated understanding of related pharmaceutical, biological, or device operations, is preferred.

About Organon

Organon is a global healthcare company focused on making a world of difference for women, their families, and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars, and touching lives with a diverse and trusted portfolio of health solutions.

Equal Employment Opportunity

Organon proudly embraces diversity in all its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.

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