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Executive Director, Global Product Regulatory

3 months ago

Jersey City, New Jersey, United States Organon Full time

The Position

Responsibilities

  • Provide Global Strategic Regulatory overview for respective products and portfolio.
  • Guide and coach GRLs in creating and implementing global regulatory strategy for registration, maintenance and market expansion of products within the portfolio.
  • Provide technical and professional leadership and conduct all appropriate HR activities such as managing performance, development planning, staffing and related peoplemanagement responsibilities for GRLs within areas of responsibility.
  • Review and approve regulatory submissions and background packages to ensure clarity and comprehensive presentation of issues.
  • Review and approve communication materials to be used external to Organon such as press releases for accuracy and consistency of message.
  • Review labeling; manage label negotiations with agencies worldwide as appropriate to obtain and maintain optimal labeling consistent with the company core data sheet.
  • Represent Organon, as needed, at external initiatives, notably with regulatory authorities.
  • Participate in projects and initiatives outside of current responsibilities, as needed, to drive the organization forward to success.
  • Contribute to determining solutions outside of current responsibilities, as needed, and manage daytoday operational issues outside of current responsibilities, as needed.
  • Work seamlessly with other R&D departments as well as commercial organization and manufacturing organizations.
  • Drive innovative and creative solutions for achieving R&D goals and objectives in a high quality and costeffective manner.

Required Education, Experience and Skills

  • B.S., M.S., M.D. or PhD in biological science, chemistry or related discipline preferred.
  • Regulatory experience required with preference for therapeutic area experience in Women's Health, general medicine or biosimilars.
  • M.D. or PhD with 712 years relevant drug development experience required preferably with 5 years in Regulatory.
  • M.S. or B.S. with 1215 years relevant drug development experience, a majority of which was in Regulatory.
  • Demonstrated scientific knowledge, writing ability, effective communication and thorough familiarity with worldwide regulatory agencies.
  • Experienced in negotiations with health authorities.
  • Outstanding interpersonal, communication and negotiation skills.
  • Demonstrated leadership attributes; experienced at building and leading high performing teams; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities.
  • Deep competency in developing optimal regulatory strategy globally and understanding of regulatory requirements throughout the development spectrum (preclinical to postmarketing).
  • Ability to solve problems through investigation and solution identification.
  • High degree of professionalism and sound judgment.
  • Driver of change and innovation.
  • Demonstrate sensitivity and knowledge of cultural differences with experience in multicountry, multicultural environments and demonstrated success with crossgeographically based cultural collaborations.

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives.

We are a $6.5 billion 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.


Our Vision is clear:
A better and healthier every day for every woman.

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Organon proudly embraces diversity in all of 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.


Search Firm Representatives Please Read Carefully

Applicable to United States Positions Only:Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with