Executive Director, Regulatory Legal

Job Description

Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.

At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.

It’s going to be an exciting future—come be a part of it!

As a trusted partner within our Company's Legal team, you will partner with our leaders to ensure we maintain our Company’s values and high ethical standards, protect our people and assets, and enhance our reputation. Organon seeks to accomplish big goals—start a new Company, create a new culture, be proactive and entrepreneurial, and impact lives of women around the globe. Organon will invest in our people and strive to foster an environment that is inspiring, supportive, transparent, empowering, and diverse. Joining Organon is an experience like no other, where you can learn, develop, and be a key contributor to deliver on our Company's mission.

Primary Responsibilities:

• Advising the organization on a wide range of FDA regulatory issues and compliance with laws, regulations, and applicable standards and policies through a drug or device’s lifecycle, including research, regulatory approvals or clearances, and advertising and promotion.

• Providing legal support for drug and device advertising and promotional reviews as part of a cross-functional team.

• Providing legal advice on issues affecting clinical and marketed products.

• Providing legal support for and review of regulatory submissions.

• Providing regulatory interpretations, defending regulatory enforcement actions, and acting as liaison with outside counsel, where appropriate.

• Provide legal advice and guidance that is consistent with law and Company policy; furthers business objectives and appropriately balances business objectives and legal risks.

• Exercise judgment to drive decisions on routine and non-routine matters within area of practice.

• Managing a team of attorneys responsible for providing guidance on a wide range of FDA regulatory issues across therapeutic areas.

Education Minimum Requirements:

• A bachelor's degree from an accredited institution.

• JD degree, Graduate of an accredited US law school, with admission to the Bar of Pennsylvania, New Jersey or another state.

Required Experience and Skills:

• Ten (10) or more years of relevant experience in a law firm or corporate setting.

• Management experience is required.

• Experience in both pharmaceutical products and medical devices is preferred.

• Experience in product liability litigation and business counseling is preferred.

• Excellent teamwork, communication (written and oral) and analytical skills, and a high degree of business acumen.

• Experience in managing a significant workload, with the ability to juggle competing tasks in a fast paced and challenging environment.

• Ability to provide timely, practical and compliant solutions while managing legal risks and demonstrating superior legal judgment.

• Ability to be proactive and take initiative.

• Ability to manage a budget in conjunction with the associate vice president and other attorneys.

• Willingness to adapt to change; motivated to learn and grow and to seek increasing areas of responsibility.

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.

Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.

Residents of Colorado: to request this role’s pay range: email: coloradopayact@organon.com

Jersey City and New York City Positions: to request this role’s pay range and benefits, email: jcnycpayact@organon.com

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:

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Organon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R510815