Vice President – Head Global Product Regulatory Strategy and US Regulatory Affairs & Affiliate Pharmacovigilance Lead

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!

The Vice President, Head Global Product Regulatory Strategy (GPRS) and US Regulatory Affairs and Affiliate Pharmacovigilance (RAaPV) Lead plays a leading role in:

Delivering Regulatory Strategic Excellence across our Company's enterprise by shaping the overall regulatory strategy and driving execution of regulatory deliverables across our development pipeline and marketed product portfolio globally. This role is accountable across the enterprise for rigour in regulatory science, pragmatism and innovation in the interpretation and application of regulatory intelligence, guidelines and regulatory precedence and ensuring excellence in regulatory execution across all areas of our Company's business. Providing leadership and functional oversight to US based RAaPV associates and ensuring partnership excellence with the US Commercial organization. This includes oversight of day-to-day regulatory deliverables and commitments associated with our Company's business and presence in the US; coaching and mentoring US based RAaPV staff; overseeing compliance with US regulatory requirements and ensuring that Organon has an excellent relationship & partnership with the US FDA at both federal and local level.

Primary Responsibilities:

1. Global Regulatory Strategy:

• Lead the development of innovative and effective regulatory strategies to inform product development, regulatory approval and successful commercialization of our pipeline assets globally.

• Strengthen our Company's overall regulatory strategic capabilities to develop and maximize the value of the pipeline through effective oversight of the asset development regulatory teams/leads and contribution to asset development plans.

• Collaborate effectively across the enterprise to drive technical regulatory input into franchise portfolio decisions and R&D functional governance.

• Ensure availability and optimal deployment of regulatory technical expertise, capabilities and resources, to manage portfolio activities, including pipeline asset screening and due diligence, drug/device development, regulatory advocacy and global marketing authorization submissions and lifecycle management activities.

• Manages the optimal communication of information around regulatory strategy throughout the enterprise and with key external stakeholders. Ensures regulatory assumptions, opportunities and risks are robust, transparent and effectively communicated and that regulatory commitments and deliverables are met.

2. Ensuring effective regulatory input into decision-making in our Company's Business Development activities:

• Ensure that scientific and regulatory assessments and input into our Company's due diligence activities are timely, robust and holistic, ensuring the regulatory perspective supports overall R&D and Business Development (BD) objectives.

• As an integral player in helping formulate ORD’s position to inform BD decisions, provide the regulatory scientific know-how and strategic interpretation to influence the decision-making process for our Company's BD opportunities, including in senior management presentations and engagement.

3. External Regulatory Engagement & Advocacy:

• In collaboration with the SVP RAaPV and other enterprise stakeholders, develop an Industry leading regulatory intelligence and advocacy infrastructure and approach that supports our leadership ambitions in Women’s Health as well as effective management of our portfolio.

• Enhance Organon’s visibility, approach and relationship with key global regulatory agencies (for e.g., FDA, EMA, NMPA, PMDA). Own our Company's relationship with FDA and guide proactive, sustainable and successful, engagement with regulatory stakeholders in line with our R&D and business objectives.

• Provide insights and lead the development of the company position and advocacy approach on critical regulatory issues and trends related to our Company's portfolio and strategic interests.

• Be a strong subject matter expert in directing our Company's approach in providing input into and evolving regulatory processes, laws, and influencing where possible the external regulatory environment.

• Ensures consistency in all communications and interactions with US FDA around all aspects of our marketed portfolio including regulatory and pharmacovigilance commitments and deliverables.

4. Enterprise Leadership & Partnership Excellence:

• Oversees a team that partners with US Commercial and delivers regulatory support to US business activities. Ensures a competitive but compliant risk posture for US advertising and promotional activities and other US business goals.

• Acts as Functional Lead in overseeing day to day welfare of US based RAaPV staff and is responsible for the US RAaPV business continuity plans.

• Role models Organon’s culture and creates a positive team environment that promotes team cohesion and performance.

Education Minimum Requirements:

• Bachelor's degree

Required Experience and Skills:

• Advanced Scientific and/or Business qualification, with minimum 10 years drug development and regulatory affairs leadership experience in a consultancy, pharma/biotech or Medtech environment. Experience in Women’s Health an advantage.

• Demonstrable experience of leading successful engagement with key regulatory authorities but especially the US FDA across all aspects of the portfolio lifecycle.

• Broad pharma industry knowledge, with extensive experience of drug development, regulatory affairs and pharmacovigilance at a global level. Broad experience and understanding of key requirements across all technical drug development areas including pre-clinical, clinical and CMC. Experience in device development and registration is an added benefit.

• Experience leading early as well as late-stage regulatory strategy and interactions with key regulatory agencies including FDA, EMA, Health Canada, NMPA, PMDA and driving successful global regulatory submissions and approvals.

• Hands on experience with IND and NDA submissions in the US and CTA/MAA submissions in the US.

• Comprehensive knowledge of global regulatory requirements and operations including updated knowledge of ICH GxP requirements.

• Proven track record in building and leading teams of skilled regulatory professionals to deliver business goals

• Experienced in decision-making at a senior level

• Fluent in written and spoken English

Technical & Leadership Competencies:

• Strong leadership skills, able to inspire and motivate colleagues to focus on business imperatives, work under pressure and achieve challenging business goals.

• Excellent judgment in risk-assessed decision-making, with a strong problem-solving approach, solution- and results-orientated.

• Self-confident and articulate, with excellent verbal and written communication skills, able to represent the company effectively in matters of regulatory science and strategy.

• Experience of leading/overseeing external vendors and effectively managing budgets and resources to support critical enterprise deliverables.

• Sensitive to diversity and inter-cultural differences, able to build effective collaborations across functional and geographic boundaries, lead change and promote learning and development for individuals and collectively.

Location:

• Role is expected to be based in Jersey City or Landsdale, PA location. However, some flexibility with regards to hybrid working arrangements. Ability to travel globally is required.

Other Useful Information

Internal and external contacts (organization):

Internally:

• All staff involved in RAaPV activities across our Company; corporate and affiliate staff including commercial; GRA; QA and Tech Ops; Clinical and Franchise teams; Medical Affairs; Safety; Clinical Development; Senior Management.

• Global Product Team members regarding regulatory, safety and clinical development activities.

• HR, IT and Finance colleagues.

• R&D LT and Executive Committee members.

Externally:
Staff from co-development/co-marketing Business Partner companies; Health Authority personnel including regulatory inspectors; consultants and vendors;

• Financial impact: Management of budget and vendors linked to critical pipline and portfolio deliverables.

• Risks: Integral in growth, development and progression of the pipeline. Lack of appropriate compliance with regulatory obligations worldwide may have significant negative implications on drug development programs and/or marketing authorizations.

• People management: Line management accountability and operational leadership of all allocated staff

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.

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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.

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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.

Salary Range

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:

Requisition ID:R515313