Director, Global Regulatory Policy and Intelligence

TN United Kingdom; Greater London; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Director for Global Regulatory Policy and Intelligence. This pivotal role involves leading regulatory initiatives across therapeutic areas and products, influencing global policy, and collaborating with various stakeholders. The ideal candidate will have a strong educational background in biological sciences or related fields, along with significant experience in regulatory affairs. Join a forward-thinking organization dedicated to improving health solutions and making a positive impact in women's health and beyond. This is an exciting opportunity to drive innovative strategies in a diverse and multicultural environment.

Benefits

Retirement Plans

Paid Leave

Health Coverage

Qualifications

• 5-10 years of experience in Regulatory Policy and Intelligence.
• Proven ability to influence international regulatory guidance.

Responsibilities

• Lead Regulatory Policy and Intelligence activities for Global Regulatory Affairs.
• Provide insights to guide product development strategy.

Skills

Regulatory Policy

Regulatory Intelligence

Strategic Policy Development

Interpersonal Skills

Negotiation Skills

Cultural Sensitivity

Collaboration with Stakeholders

Knowledge of AI and Machine Learning

Education

M.S., M.D., PhD in Biological Sciences

PharmD

Job description

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Director, Global Regulatory Policy and Intelligence, gbr - england - england

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Client:

Organon

Location:

gbr - england - england, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

2f3040a22204

Job Views:

13

Posted:

28.04.2025

Expiry Date:

12.06.2025

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Job Description:

Job Description

The Position

The successful candidate will lead Regulatory Policy and Intelligence activities for Global Regulatory Affairs, covering all Therapeutic Areas, products, and regions of interest to Organon.

Responsibilities

• Provide Global Regulatory Policy and Intelligence insights to guide product development strategy for R&D portfolio.
• Identify key Regulatory Policy areas for Organon to focus on and propose initiatives.
• Represent Organon at key Regulatory Policy meetings related to R&D.
• Champion policy initiatives with external partners, especially regulatory authorities.
• Oversee Regulatory Intelligence activities and disseminate pertinent information to senior leadership.
• Participate in projects outside primary responsibilities to drive organizational success.
• Collaborate with R&D, commercial, and manufacturing departments.
• Drive innovative solutions for achieving R&D goals efficiently and effectively.

Required Education, Experience and Skills

• M.S., M.D., PhD in biological sciences, chemistry, or related fields, or PharmD with 5-10 years’ industry or academic experience.
• Proven Regulatory Policy and Intelligence professional influencing international regulatory guidance.
• Experience in developing and implementing strategic policy priorities globally.
• Ability to build effective relationships with regulators.
• Experience collaborating with international stakeholders to promote convergence in policy and strategy.
• Involvement with trade associations like BIO, PhRMA, EFPIA.
• Knowledge of emerging technologies (AI, machine learning, cloud) in regulatory contexts.
• Excellent interpersonal, communication, and negotiation skills.
• Sensitivity to cultural differences and success in multicultural environments.

Secondary Language(s) Job Description

Who We Are:

Organon delivers health solutions to improve lives, focusing on Women's Health, biosimilars, and diverse health solutions. Our vision is a better, healthier everyday for every woman.

US and PR Residents Only

Organon is committed to diversity and equal opportunity employment, respecting all protected characteristics.

Salary and Benefits: The salary range varies by country and is based on location, skills, and experience. Benefits include retirement plans, paid leave, and health coverage.

Additional Details:

• Employee Status: Regular
• Relocation: No
• VISA Sponsorship: Yes/No (not specified)
• Travel Requirements: Must meet travel and vaccination requirements
• Shift: Not specified
• Driving License: Not specified
• Hazardous Materials: Not specified
• Number of Openings: 1