Director, Regulatory Affairs Strategy

5-8 years

Not Disclosed

Princeton Junction

10 July 10, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position Information:

Employer: Genmab
Category: Global Regulatory Affairs (GRA)
Location:
- Country: United States
- State: New Jersey (NJ)
- City: Princeton
Onsite Requirement: 60% onsite presence per hybrid policy

Company Information:

Genmab is committed to building extraordinary futures by developing antibody products and pioneering therapies that change patients' lives and the future of cancer treatment and serious diseases. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science. We believe in being unique, determined, and authentic to fulfill our purpose.

The Role:

Genmab is looking for an experienced and passionate leader to join our Global Regulatory Affairs (GRA) organization. In this role, you will develop global and US regulatory strategies to advance Genmab’s portfolio of development pipeline candidate drugs. You will provide strategic input and ensure operational execution of global and US submission activities. You will be the primary contact for the US FDA for assigned programs.

This position reports to the Regulatory Strategy Team Lead.

Key Responsibilities:

Act as the US/Global Regulatory Leader (GRL) for assigned projects.
Develop, implement, and maintain US/global regulatory strategies in line with the Product Development Plan.
Represent GRA in Compound Development Teams (CDT) to meet project deliverables.
Lead the Global Regulatory Team (GRT) and Submission Team(s).
Participate in Clinical Trial Teams as required.
Ensure regulatory strategies throughout life-cycle management for approved products.
Evaluate regulatory risk and recommend mitigation strategies.
Lead the development of briefing materials and prepare teams for US/global health authority meetings.
Participate in the development and review of submission documentation for INDs/CTAs and marketing applications.
Evaluate regulatory mechanisms to optimize product development and present recommendations.
Collaborate with the Labeling team to develop the Company Core Data Sheet and US Prescribing Information.
Consult with senior management on regulatory strategies and advice.
Interact with the US FDA and global health agencies for assigned projects.
Monitor and assess regulatory guidelines, regulations, and the current regulatory environment.
Maintain updated knowledge of regulatory topics and regulations.
Build relationships with key external stakeholders.
Provide regulatory due diligence assessment of licensing/acquisition opportunities as assigned.

Requirements:

Education: BSc or MSc in life sciences (PharmD, PhD preferred).
Experience:
- Minimum 5-8 years in Regulatory Affairs (Oncology and/or immunology preferred).
- Direct interaction/negotiation with regulatory authorities (e.g., FDA, EMA).
- Solid understanding of drug development, including early and late development.
- Broad knowledge of life-cycle management.
Skills:
- Strong strategic skills and ability to make complex decisions.
- Solid knowledge of global and US regulations and the US pharmaceutical market.
- Strong organizational, communication, and time management skills.
- Attention to detail and problem-solving ability.
- Ability to work independently and drive projects to successful outcomes.
- Ability to influence others and resolve conflicts.
- Highly motivated and self-driven.
Salary: $170,625.00 - $284,375.00 (dependent on skills, qualifications, experience, and location).
Additional Compensation: Eligible for bonuses.

About You:

Passionate about transforming lives through innovative cancer treatment.
Rigorous and excellent in approach to problem-solving.
Collaborative and able to work in diverse teams.
Determined to do and be the best.
Innovative and comfortable with the unknown.
Experience in a fast-growing, dynamic company.
Enjoy working hard and having fun.

Locations:

Genmab offers an agile working environment to enhance work-life balance. Our offices are community-based spaces designed to connect employees and support innovation, whether onsite or remote.

About Genmab:

Genmab is an international biotechnology company focused on improving patients' lives through innovative antibody therapeutics. With over 20 years of experience, our team has developed next-generation antibody technology platforms and a proprietary pipeline, including bispecific T-cell engagers, immune checkpoint modulators, enhanced antibodies, and antibody-drug conjugates. We have formed 20+ strategic partnerships to develop and deliver novel therapies.

Headquartered in Copenhagen, Denmark, Genmab has locations in Utrecht, the Netherlands; Princeton, New Jersey; and Tokyo, Japan.

Diversity, Equity, and Inclusion:

Genmab is committed to fostering workplace diversity and ensuring equal employment opportunity without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic information, or veteran status. Learn more about our commitments on our website.

Privacy Policy: Genmab is committed to protecting personal data and privacy. Please see our privacy policy on our website for more information.

Netherlands Policy: For positions in the Netherlands, Genmab initially offers a fixed-term employment contract for a year, with potential renewal for an indefinite term based on performance and business conditions.

Application:

To apply, please visit our website Genmab Careers.

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