Associate Director, Regulatory Legal_

Plymouth Meeting

**Job Description**

**The Position**

The successful candidate will provide legal support and counseling to business clients on a wide range of FDA regulatory and compliance issues (including GxP compliance) for the commercial, research & development, and manufacturing organizations.

**Responsibilities**

+ Partnering with various stakeholders to perform risk assessments on proposed concepts and provide practical, solutions-oriented advice that meets business objectives while minimizing regulatory risk for the organization.

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

+ Providing legal support to the commercial organization as a member of the Promotion Review Committee.

+ Providing day-to-day legal advice to the labeling, quality, supply chain, and regulatory organizations in R&D and Manufacturing.

+ Preparing business clients for regulatory inspections.

+ Providing legal support for and review of regulatory submissions.

+ Providing legal advice on issues affecting clinical assets and marketed products.

+ Providing regulatory legal guidance on a range of additional issues including state licensing and environmental, health, and safety issues in the US.

+ The successful candidate will also provide subject matter support to business development opportunities, quality investigations, pharmacovigilance agreements, supply agreements, quality agreements, and issues involving trade compliance.

**Required** **Education, Experience and Skills**

+ A Bachelor's degree from an accredited institution.

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

+ At least five (5) or more years of legal experience in a law firm or corporate setting.

+ 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.

+ Experience operating in ambiguous circumstances.

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

+ Ability to be proactive and take initiative.

+ Prior experience with pharmaceutical products required.

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**Preferred Experience and Skills**

+ Experience with combination products and medical devices preferred.

+ Prior GxP and FDA regulatory experience preferred.

Up to 10% travel

**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 [email protected] .

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)**

$150,600.00 - $256,300.00

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

**Employee Status:**

Regular

**Relocation:**

No relocation

**VISA Sponsorship:**

No

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

10%

**Flexible Work Arrangements:**

Flex Time, Telecommuting

**Shift:**

**Valid Driving License:**

**Hazardous Material(s):**

**Number of Openings:**

1

**Requisition ID:** R526606