Job Abstract

Job Description

The Position

The successful candidate will lead a group of Global Regulatory Leads (GRLs), who are responsible for development and implementation of world-wide regulatory strategies for their assigned projects. This may include products in all phases of development through registration and mature products. The Executive Director could also support business development due diligence activities.

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 people-management 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 day-to-day 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 cost-effective 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 7-12 years relevant drug development experience required preferably with 5 years in Regulatory.

• M.S. or B.S. with 12-15 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 post-marketing).

• 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 multi-country, multi-cultural environments and demonstrated success with cross-geographically 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.

US and PR Residents Only

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

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 
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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 the terms and conditions of the applicable plans.

Annualized Salary Range (US)

Please Note: Pay Ranges are Specific to local market and therefore vary from country to country

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings: