VP Regulatory Affairs Big Pharma – New York, NY

Are you an experienced regulatory leader ready to take on a pivotal executive role in the pharmaceutical industry? We are seeking a Vice President of Regulatory Affairs to join a globally recognized pharmaceutical company headquartered in New York, NY. This is a rare opportunity to influence product development, ensure global compliance, and lead strategic regulatory initiatives in a highly innovative environment. If you thrive in a high-stakes, high-impact role and bring deep expertise in regulatory strategy, this position is for you.

Drive Regulatory Excellence in a Leading Pharmaceutical Company

A global leader in the pharmaceutical industry is seeking a Vice President of Regulatory Affairs to oversee all regulatory functions from early development through product approval and post-marketing. Based in New York, NY, this role requires a seasoned executive with in-depth knowledge of FDA and international regulatory pathways, exceptional leadership skills, and the ability to collaborate cross-functionally with R&D, clinical, and commercial teams. Join a mission-driven organization where your expertise will help bring life-changing therapies to patients worldwide.

Key Responsibilities of the Vice President (VP) – Regulatory Affairs – Big Pharma

Regulatory Strategy Development:
Lead the creation and execution of comprehensive regulatory strategies across global markets, including the U.S., EU, and emerging regions. Provide guidance throughout the drug development lifecycle to ensure alignment with evolving regulatory requirements and business objectives.

Product Lifecycle Oversight:
Oversee regulatory activities from early-stage development through commercialization and post-marketing surveillance. Ensure timely preparation, submission, and approval of INDs, NDAs, BLAs, MAAs, and other critical filings.

Cross-Functional Collaboration:
Partner with R&D, Clinical, Quality, Legal, and Commercial teams to integrate regulatory perspectives into key business decisions. Serve as a strategic advisor in cross-functional meetings, ensuring regulatory risks and opportunities are proactively addressed.

Regulatory Agency Engagement:
Act as the primary liaison with the FDA and other international regulatory bodies. Lead the preparation for regulatory meetings, manage agency interactions, and ensure clear, consistent communication on product development plans and compliance issues.

Team Leadership & Talent Development:
Lead and mentor a high-performing regulatory affairs team. Foster a culture of continuous learning, accountability, and regulatory excellence. Develop succession plans and support career progression for team members.

Compliance & Risk Management:
Ensure adherence to all applicable laws, guidelines, and industry standards. Develop and implement policies and procedures to mitigate regulatory and compliance risks across the organization.

Global Regulatory Intelligence:
Monitor changes in the global regulatory landscape and assess their impact on the company’s product portfolio and pipeline. Translate regulatory trends into actionable strategies and ensure company-wide awareness of key developments.

Strategic Portfolio Support:
Provide regulatory input into portfolio planning and prioritization. Assess regulatory feasibility of new business opportunities, acquisitions, or partnerships to support long-term growth initiatives.

Quality & Documentation Excellence:
Ensure regulatory submissions are of the highest quality, accurate, and submitted in a timely manner. Oversee document management systems and ensure compliance with eCTD and other regulatory standards.

Executive & Board Reporting:
Provide regular updates to executive leadership and the board of directors on regulatory strategy, submission progress, and risk assessments. Contribute to investor presentations and strategic business planning discussions.

What the Client is Looking for in You

As the Vice President (VP) of Regulatory Affairs – Big Pharma, the client seeks a highly strategic, detail-oriented, and experienced regulatory leader with a proven ability to navigate global regulatory frameworks, guide cross-functional teams, and ensure successful product approvals. You should be a decisive and collaborative executive who thrives in a fast-paced, innovation-driven environment and can lead with both expertise and vision.

Extensive Regulatory Affairs Experience in the Pharmaceutical Industry
The client is looking for a senior executive with a strong background in regulatory affairs within the pharmaceutical or biotech sector. You should bring deep knowledge of FDA, EMA, and ICH regulatory requirements and a successful track record of leading submissions and approvals across multiple therapeutic areas. Experience managing regulatory teams in a global context is highly valued.

Strategic Vision with Operational Execution
The ideal candidate must demonstrate the ability to shape long-term regulatory strategies that align with the company’s pipeline goals and commercialization plans. You should be capable of integrating regulatory insights into product development while navigating complex timelines and compliance risks. The client values forward-thinking leaders who can anticipate regulatory changes and proactively adapt strategies.

Strong Cross-Functional Leadership
You will be expected to work closely with R&D, Clinical Development, Quality Assurance, Legal, and Commercial teams. The client is looking for someone who can lead cross-functional collaboration, build consensus, and provide regulatory guidance that influences high-stakes business decisions.

Proven Success in Global Regulatory Submissions
Experience preparing, submitting, and gaining approval for major regulatory filings (INDs, NDAs, BLAs, MAAs) is critical. The client seeks a VP who can oversee submission strategy, manage timelines, and maintain high-quality documentation to meet both U.S. and international regulatory standards.

Expertise in Agency Interactions
The ability to lead regulatory interactions with agencies such as the FDA and EMA is essential. The ideal candidate will be a confident communicator who can present development strategies, defend clinical trial designs, and negotiate successful outcomes during agency meetings.

Team Development and Mentorship
The client is looking for a leader who can attract and develop top regulatory talent while fostering a culture of accountability, transparency, and continuous improvement. A strong commitment to mentoring and empowering others is key to building a best-in-class regulatory organization.

Commitment to Compliance and Ethical Standards
You must be vigilant in ensuring that all regulatory activities comply with global laws, ethical standards, and corporate policies. The client values leaders with a sharp eye for risk management and a disciplined approach to process integrity and documentation control.

Strong Communication and Executive Presence
As a senior leader, you must be able to communicate complex regulatory concepts to internal stakeholders, executive leadership, and board members. The client values clarity, confidence, and the ability to influence and advocate for regulatory priorities at the highest levels of the organization.

FAQs About the Role – Vice President (VP) Regulatory Affairs – Big Pharma

What are the key responsibilities of the VP Regulatory Affairs in this role?
As the Vice President of Regulatory Affairs, you will lead the development and execution of global regulatory strategies, oversee all regulatory submissions and agency interactions, ensure compliance with regulatory requirements, and provide strategic guidance throughout the product lifecycle. You will also manage and mentor the regulatory team and collaborate closely with cross-functional partners to support product development and commercialization.
What qualifications and experience are required for this position?
The ideal candidate should have extensive experience in pharmaceutical regulatory affairs, with a proven track record of managing global regulatory submissions (INDs, NDAs, BLAs, MAAs). A strong understanding of FDA, EMA, and other international regulatory frameworks is essential. Experience leading regulatory teams in a fast-paced, innovation-driven environment is highly preferred. Advanced degrees in life sciences or related fields and relevant regulatory certifications are advantageous.
What leadership qualities are essential for this role?
The client seeks a strategic, collaborative, and results-oriented leader who can influence cross-functional teams and navigate complex regulatory landscapes. Strong communication skills, decision-making ability, and a commitment to fostering a culture of compliance and continuous improvement are critical. You should be adept at managing multiple priorities while maintaining high standards of quality and integrity.
What challenges can I expect in this role?
You will face challenges such as keeping pace with evolving global regulatory requirements, managing tight submission timelines, coordinating regulatory strategy across diverse markets, and mitigating regulatory risks. The role demands agility in responding to regulatory changes while supporting innovative product development and ensuring successful market access.
What is the expected impact of the VP Regulatory Affairs on the company’s success?
The VP Regulatory Affairs will play a pivotal role in enabling timely product approvals, minimizing regulatory risks, and supporting strategic business goals. Your leadership will directly influence the company’s ability to bring innovative therapies to market, maintain regulatory compliance, and sustain long-term growth and competitive advantage.
What is the company’s culture and work environment like?
The company promotes a culture of scientific innovation, regulatory excellence, and collaboration. It values leaders who are proactive, ethical, and committed to driving results through teamwork. You will have the opportunity to work in a supportive, fast-paced environment that encourages professional growth and continuous learning.

What Remuneration Can You Expect from This Job?

As the Vice President (VP) of Regulatory Affairs in a leading Big Pharma company based in New York, NY, you can expect a competitive and comprehensive compensation package designed to attract and retain top regulatory leadership talent. The remuneration for this role typically includes:

Base Salary
The base salary for a VP of Regulatory Affairs in the pharmaceutical industry varies depending on the company size, therapeutic area, and candidate experience. For large, global pharmaceutical companies, the annual base salary typically ranges from $200,000 to $350,000.
Performance-Based Bonuses
In addition to the base salary, performance-based bonuses linked to individual and company performance are common. These bonuses often range from 20% to 50% of the base salary, rewarding successful regulatory submissions, compliance milestones, and strategic leadership achievements.
Equity & Stock Options
Many Big Pharma companies offer equity incentives such as stock options or restricted stock units (RSUs) to align your interests with long-term shareholder value. These equity awards can constitute a meaningful part of the total compensation, especially in publicly traded firms.
Long-Term Incentive Plans (LTIPs)
Some organizations provide LTIPs that reward sustained performance and leadership over multiple years, ensuring a focus on long-term regulatory success and business growth.
Executive Benefits & Perks
VPs typically receive a robust benefits package that may include:

Comprehensive health, dental, and vision insurance
Retirement plans such as 401(k) with company matching
Executive wellness programs
Flexible work arrangements and professional development support
Travel allowances and business expense reimbursements

Signing Bonuses & Relocation Assistance
To attract highly qualified candidates, companies may offer signing bonuses or relocation packages. These incentives vary widely but can be substantial depending on the candidate’s background and company policy.

Total Compensation Potential

When considering base salary, bonuses, equity, and additional incentives, total compensation for a VP of Regulatory Affairs in Big Pharma can range from $300,000 to $600,000 or more annually. Exceptional candidates in high-impact roles at leading companies may earn beyond this range.

How to Apply

If you are an experienced and visionary regulatory leader with a proven track record in the pharmaceutical industry, we encourage you to apply for the Vice President (VP) Regulatory Affairs role in New York, NY. This is a rare opportunity to lead regulatory strategy at a top-tier Big Pharma company, ensuring compliance, facilitating successful product approvals, and driving innovation in a highly regulated environment.

To apply, please submit your updated resume along with a cover letter outlining your expertise in regulatory affairs leadership, regulatory strategy development, compliance management, and cross-functional team collaboration. Emphasize your experience navigating complex regulatory landscapes, managing submissions across multiple regions, and fostering strong relationships with regulatory agencies.

This role offers a high-impact career path where you will influence critical decisions, support business growth, and ensure regulatory excellence. Apply today to take your regulatory leadership career to the next level as VP Regulatory Affairs in Big Pharma!

For more information or to explore additional pharmaceutical leadership opportunities, please visit our Big Pharma Recruiting Experts page.

Job Category: Big Pharma

Job Type: Full Time

Job Location: New York

VP Regulatory Affairs Big Pharma – New York, NY