VP of Regulatory Affairs – Drug-Device Submissions | Washington, DC

Are you an experienced regulatory leader passionate about navigating the complex landscape of drug-device combination products? We are seeking a Vice President of Regulatory Affairs to spearhead regulatory strategies and submissions for cutting-edge drug-device innovations based in Washington, DC. This is a unique opportunity to lead cross-functional teams, ensure compliance with evolving regulatory requirements, and support product development that improves patient outcomes.

Lead Regulatory Strategy for Drug-Device Products in Washington, DC

A leading healthcare company located in Washington, DC is looking for a visionary Vice President of Regulatory Affairs to manage and optimize drug-device submission processes. The ideal candidate will have deep expertise in FDA regulatory frameworks, exceptional leadership skills, and a track record of successfully navigating combination product approvals. If you thrive on ensuring regulatory excellence while enabling innovation, this role offers a chance to influence critical decisions in a rapidly evolving industry.

Key Responsibilities of the Vice President of Regulatory Affairs – Drug-Device Submissions

Regulatory Strategy & Leadership: Develop and execute comprehensive regulatory strategies for drug-device combination products, ensuring alignment with corporate goals and compliance with FDA and other global health authorities. Lead regulatory teams to anticipate regulatory trends and influence regulatory policy when applicable.

Submission Management: Oversee the preparation, review, and successful submission of regulatory dossiers including INDs, NDAs, BLAs, PMAs, 510(k)s, and combination product filings. Ensure timely, accurate, and high-quality regulatory submissions that meet all agency requirements.

Cross-Functional Collaboration: Partner closely with R&D, clinical, quality assurance, manufacturing, and marketing teams to integrate regulatory requirements early in product development and throughout the product lifecycle. Facilitate clear communication and regulatory guidance across departments.

Regulatory Compliance & Risk Mitigation: Ensure all drug-device products comply with applicable regulations and guidelines. Proactively identify regulatory risks and develop mitigation strategies to safeguard product approval timelines and market access.

Team Development & Leadership: Build, mentor, and lead a high-performing regulatory affairs team. Foster a culture of continuous learning, accountability, and innovation while maintaining high standards of professional excellence.

Agency Interaction & Negotiation: Serve as the primary regulatory liaison with FDA and other regulatory bodies. Manage meetings, negotiations, and audits with agencies to advocate effectively for product approvals and compliance.

Global Regulatory Alignment: Support global regulatory strategy by coordinating with international regulatory counterparts to facilitate product registrations in multiple markets and ensure harmonized regulatory approaches.

Documentation & Reporting: Maintain thorough and organized regulatory documentation, ensuring transparency and audit readiness. Provide senior leadership with regular updates on regulatory status, risks, and strategic recommendations.

Regulatory Intelligence & Policy Monitoring: Stay abreast of evolving regulatory requirements and industry trends affecting drug-device products. Implement processes to integrate regulatory intelligence into business decision-making.

What the Client is Looking for in You

As the Vice President of Regulatory Affairs for Drug-Device Submissions, the client is seeking a highly experienced regulatory leader who can expertly navigate the complexities of combination product regulations while driving strategic initiatives that accelerate product approvals and market access. You should be a proactive, detail-oriented executive with a strong regulatory mindset and proven ability to lead cross-functional teams in a fast-evolving healthcare environment.

Proven Expertise in Drug-Device Regulatory Affairs

The client values a candidate with extensive hands-on experience in managing regulatory submissions for drug-device combination products, including INDs, NDAs, BLAs, PMAs, and 510(k)s. You should have a deep understanding of FDA regulatory pathways and global regulatory requirements, with a demonstrated history of successful product approvals and compliance management.

Strategic Vision with Regulatory Leadership

You must have the ability to develop and execute comprehensive regulatory strategies that support product development and commercial objectives. The ideal candidate anticipates regulatory changes, influences agency interactions, and aligns regulatory goals with business priorities to ensure smooth and timely product launches.

Strong Cross-Functional Collaboration and Communication Skills

The client seeks a leader who excels in partnering with R&D, clinical, quality, and commercial teams to integrate regulatory considerations early and throughout the product lifecycle. You should communicate regulatory requirements clearly and effectively to diverse stakeholders, ensuring alignment and informed decision-making.

Team Builder and Mentor

Leadership and talent development are critical for this role. The client wants a VP who can build and inspire a high-performing regulatory affairs team, fostering a culture of continuous improvement, accountability, and innovation.

Regulatory Intelligence and Risk Management

You should be adept at monitoring evolving regulatory landscapes and proactively managing risks related to compliance and product approvals. The client values your ability to incorporate regulatory intelligence into strategic planning to maintain competitive advantage and regulatory compliance.

Strong Agency Relationship Management

Experience managing direct interactions, negotiations, and audits with FDA and other regulatory agencies is essential. The ideal candidate is skilled at representing the company’s interests, resolving regulatory challenges, and fostering constructive agency relationships.

FAQs About the Role – Vice President of Regulatory Affairs – Drug-Device Submissions

1. What are the key responsibilities of the VP of Regulatory Affairs in this role?
As the VP of Regulatory Affairs, you will lead the regulatory strategy for drug-device combination products, oversee submissions to the FDA and other agencies, ensure compliance with evolving regulations, and manage cross-functional collaboration to support product development. You will also lead a team of regulatory professionals and serve as the primary liaison with regulatory bodies to secure timely product approvals.

2. What qualifications and experience are required for this position?
The ideal candidate should have extensive experience in regulatory affairs within the pharmaceutical and medical device industries, especially with drug-device combination products. A deep understanding of FDA regulations, global regulatory requirements, and a successful track record of managing INDs, NDAs, BLAs, PMAs, and 510(k) submissions is essential. Advanced degrees in life sciences or regulatory affairs certifications are highly desirable.

3. What leadership qualities are essential for this role?
Strong leadership, strategic thinking, and excellent communication skills are critical. You should be able to lead and motivate a regulatory team, foster collaboration across departments, and effectively negotiate with regulatory agencies. Being proactive, detail-oriented, and adaptable in a highly regulated and fast-changing environment is key.

4. What challenges can I expect in this role?
You may face challenges such as navigating complex and evolving regulatory frameworks for combination products, managing tight submission timelines, and balancing regulatory requirements with business goals. Staying ahead of regulatory changes and effectively managing agency interactions will be crucial.

5. How does this role impact the company’s success?
Your leadership in regulatory affairs will be instrumental in enabling the successful development and approval of innovative drug-device products, accelerating time-to-market, and ensuring compliance. This will directly contribute to the company’s growth, competitive advantage, and reputation in the healthcare industry.

6. What is the company culture and work environment like?
The company promotes a collaborative, innovative, and compliance-focused culture. It values teamwork, continuous learning, and a commitment to high-quality standards. You will work in a dynamic environment with opportunities to influence critical regulatory strategies and contribute to meaningful healthcare advancements.

What Remuneration Can You Expect from This Job?

As the Vice President of Regulatory Affairs for Drug-Device Submissions based in Washington, DC, you can expect a competitive and comprehensive compensation package designed to attract highly qualified regulatory leaders. The remuneration typically includes:

1. Base Salary
The base salary for a VP of Regulatory Affairs in the drug-device industry varies depending on the company size, product portfolio complexity, and geographic location. Typically, annual base salaries range from $180,000 to $300,000, with higher salaries offered by larger pharmaceutical or medical device firms.

2. Performance-Based Bonuses
In addition to the base salary, you may be eligible for annual performance bonuses tied to regulatory submission milestones, successful product approvals, and overall team performance. These bonuses can range from 20% to 50% of the base salary, depending on individual and company results.

3. Equity & Long-Term Incentives
Many companies offer equity compensation such as stock options, restricted stock units (RSUs), or performance shares. These incentives align your interests with the company’s long-term success and can add significant value over time, especially in publicly traded organizations or high-growth companies.

4. Profit-Sharing & Additional Incentives
Some organizations include profit-sharing plans or long-term incentive programs that reward sustained leadership performance and regulatory success across product pipelines.

5. Executive Benefits & Perks
Expect a robust benefits package, including:

Health, dental, and vision insurance
Retirement plans with company matching (e.g., 401(k))
Paid time off and flexible work arrangements
Professional development and certification support
Executive wellness programs
Travel allowances or company-sponsored travel related to regulatory meetings and conferences

6. Signing Bonuses & Relocation Assistance
Highly qualified candidates may receive signing bonuses and relocation support to facilitate a smooth transition to Washington, DC. These one-time incentives can range from $20,000 to $100,000, depending on the company and candidate profile.

Total Compensation Potential

When factoring in base salary, bonuses, equity, and other incentives, total annual compensation for the VP of Regulatory Affairs role can range from approximately $250,000 to $450,000 or more, reflecting the critical nature of this leadership position in driving regulatory success and product approval timelines.

How to Apply

If you are a seasoned regulatory leader with deep expertise in drug-device submissions and a proven track record of driving successful regulatory strategies, we invite you to apply for the Vice President of Regulatory Affairs position based in Washington, DC. This is a rare opportunity to lead regulatory efforts for innovative combination products and make a significant impact on product approvals and compliance in a highly regulated industry.

To apply, please submit your resume and a cover letter outlining your experience with FDA and global regulatory submissions, leadership of regulatory teams, and your ability to navigate complex regulatory frameworks for both drugs and devices. Highlight your successes in driving product approvals, managing cross-functional collaborations, and ensuring compliance while accelerating time-to-market.

This role offers a critical leadership opportunity where you will shape regulatory strategy, lead submissions for cutting-edge drug-device products, and partner closely with R&D, quality, and commercial teams to ensure regulatory excellence. Apply today to advance your career as a Vice President of Regulatory Affairs – Drug-Device Submissions in Washington, DC!

For more information or to explore similar regulatory leadership roles, visit our Top Executive Search Firm for Drug-Device Combination Product Talent page.

Job Category: Drug-Device Submissions

Job Type: Full Time

Job Location: Washington

VP of Regulatory Affairs – Drug-Device Submissions | Washington, DC