Chief Regulatory Strategist – FDA Combination Product Submissions | Washington, DC

Are you an expert in regulatory affairs with a deep understanding of FDA combination product submissions? We are seeking a Chief Regulatory Strategist to join a leading life sciences organization in Washington, DC. This senior role offers a unique opportunity to shape regulatory strategies, streamline submission processes, and ensure compliance in a highly regulated and evolving industry. If you excel at navigating complex FDA requirements and thrive in a collaborative environment, this role is designed for you.

Drive FDA Compliance and Innovation for Combination Products

A prestigious life sciences company based in Washington, DC is looking for a Chief Regulatory Strategist to lead its regulatory submission efforts specifically focused on combination products. The ideal candidate will possess extensive knowledge of FDA regulations, exceptional strategic thinking skills, and a proven track record in successfully managing complex product submissions. If you are passionate about regulatory excellence and influencing product development from a compliance perspective, this is your chance to lead impactful regulatory initiatives in a cutting-edge sector.

Key Responsibilities of the Chief Regulatory Strategist – FDA Combination Product Submissions

Regulatory Strategy Development:
Formulate and lead comprehensive regulatory strategies for FDA combination product submissions. Ensure alignment with evolving FDA guidance and regulatory frameworks to streamline product approvals and lifecycle management.

Submission Management:
Oversee the preparation, review, and submission of regulatory filings, including INDs, NDAs, BLAs, 510(k)s, PMAs, and combination product-specific submissions. Manage timelines, cross-functional collaboration, and FDA interactions to ensure timely approvals.

Cross-Functional Leadership:
Collaborate closely with R&D, clinical, quality assurance, manufacturing, and legal teams to integrate regulatory requirements early in product development and manufacturing processes.

FDA Liaison & Regulatory Intelligence:
Serve as the primary point of contact for FDA communications related to combination products. Monitor regulatory changes, guidance updates, and industry trends to proactively adjust strategies and maintain compliance.

Risk Assessment & Mitigation:
Identify potential regulatory risks and challenges in combination product submissions. Develop mitigation plans and lead corrective actions to minimize impact on project timelines and market access.

Policy Advocacy & Compliance:
Advocate for regulatory policies that support innovative combination products and ensure company adherence to FDA regulations, industry standards, and ethical practices.

Training & Development:
Lead regulatory training initiatives for internal teams to build awareness and expertise in FDA combination product requirements, submission processes, and compliance best practices.

Documentation & Reporting:
Ensure accuracy and completeness of regulatory documentation. Prepare detailed reports and presentations for senior leadership, regulatory authorities, and external stakeholders.

What the Client is Looking for in You

As the Chief Regulatory Strategist – FDA Combination Product Submissions, the client is seeking a highly experienced regulatory leader with a proven track record in navigating the complexities of FDA regulations for combination products. You should be a strategic thinker with exceptional regulatory expertise, capable of guiding product development and submission strategies in a fast-evolving regulatory environment.

Proven Expertise in FDA Combination Product Regulations

The client values a candidate with deep knowledge and hands-on experience in FDA combination product regulatory pathways, including INDs, NDAs, BLAs, 510(k)s, and PMAs. You should have demonstrated success in managing complex submission projects and interacting effectively with FDA officials to achieve approvals.

Strategic Regulatory Leadership

You will need to develop and execute forward-looking regulatory strategies that align with corporate goals and market demands. The ideal candidate anticipates regulatory changes, adapts strategies accordingly, and proactively mitigates risks to ensure smooth product approvals and market access.

Strong Cross-Functional Collaboration Skills

This role requires the ability to work seamlessly across R&D, clinical, quality, manufacturing, and legal teams. The client seeks a leader who can foster collaboration, ensuring regulatory requirements are integrated early and throughout the product lifecycle.

Exceptional Communication and Negotiation Abilities

Effective communication with FDA authorities, internal stakeholders, and external partners is essential. You should be skilled in negotiating regulatory pathways, resolving compliance issues, and presenting complex regulatory concepts clearly to senior leadership.

Analytical and Problem-Solving Mindset

The client is looking for someone who can identify regulatory risks and challenges early, develop robust mitigation plans, and implement solutions efficiently. You should be detail-oriented, data-driven, and adept at balancing regulatory rigor with business objectives.

Commitment to Compliance and Ethical Standards

Maintaining full compliance with FDA regulations and industry best practices is paramount. You should be a trusted steward of regulatory integrity, ensuring all submissions and processes adhere to the highest ethical standards.

Ability to Mentor and Build Regulatory Expertise

Beyond individual contributions, the client values a leader who can train and develop internal teams, building organizational regulatory knowledge and readiness for future product innovations.

FAQs About the Role – Chief Regulatory Strategist – FDA Combination Product Submissions

1. What are the key responsibilities of the Chief Regulatory Strategist in this role?
As the Chief Regulatory Strategist, you will lead the development and execution of regulatory strategies for FDA combination product submissions. You will oversee submission preparation, ensure compliance with FDA regulations, manage cross-functional collaboration, and serve as the main liaison with FDA authorities. Driving timely approvals while mitigating regulatory risks will be central to your role.

2. What qualifications and experience are required for this position?
The ideal candidate will have extensive experience in regulatory affairs, particularly with FDA combination products and related submission pathways (e.g., IND, NDA, BLA, 510(k), PMA). A strong background in life sciences, pharmaceutical or medical device regulatory environments, and proven success managing complex FDA submissions is essential. Advanced degrees or certifications in regulatory affairs are highly desirable.

3. What leadership qualities are essential for this role?
The client seeks a strategic and proactive leader with excellent communication and negotiation skills. You should be adept at fostering collaboration across R&D, clinical, quality, and legal teams while guiding regulatory strategy. Strong problem-solving abilities, attention to detail, and the capacity to manage multiple projects under tight timelines are critical.

4. What challenges can I expect in this role?
You will face challenges such as navigating evolving FDA regulations, managing complex submission requirements for combination products, and aligning regulatory strategy with product development goals. Balancing innovation with regulatory compliance and responding swiftly to FDA feedback are also key challenges.

5. What is the expected impact of the Chief Regulatory Strategist on the company?
You will play a pivotal role in accelerating product approvals, ensuring regulatory compliance, and enabling market access for innovative combination products. Your strategic input will directly influence product success, company reputation, and competitive advantage in a highly regulated environment.

6. What is the company’s culture and work environment like?
The company promotes a collaborative, dynamic, and innovation-focused culture. It values regulatory excellence, transparency, and continuous learning. You will work with cross-functional teams dedicated to developing cutting-edge healthcare solutions, supported by leadership committed to regulatory integrity and strategic growth.

What Remuneration Can You Expect from This Job?

As the Chief Regulatory Strategist – FDA Combination Product Submissions based in Washington, DC, you can expect a competitive and comprehensive compensation package designed to attract top regulatory leaders with specialized expertise. The remuneration for this critical role typically includes:

1. Base Salary
The base salary for a senior regulatory strategist in the FDA combination products space generally ranges from $150,000 to $250,000 annually. The exact figure depends on your experience, qualifications, and the company’s size and stage.

2. Performance-Based Bonuses
In addition to your base salary, you may receive annual performance bonuses tied to regulatory milestones, successful submissions, compliance achievements, and overall business impact. Bonuses typically range from 15% to 40% of your base salary.

3. Equity & Stock Options
Many companies offer equity incentives such as stock options or restricted stock units (RSUs) to align your long-term interests with company growth. Depending on the company’s valuation and stage, equity can represent a significant portion of your overall compensation.

4. Long-Term Incentive Plans (LTIPs)
Some organizations provide LTIPs that reward sustained regulatory success and strategic contributions over multiple years. These incentives encourage a focus on long-term product approval pipelines and regulatory compliance.

5. Comprehensive Benefits & Perks
You can expect a robust benefits package that may include:

Health, dental, and vision insurance
Retirement plans with company matching
Paid time off and flexible working arrangements
Professional development support and industry conference allowances
Wellness programs and employee assistance resources

6. Signing Bonuses & Relocation Assistance
For highly qualified candidates, companies may offer signing bonuses or relocation assistance to facilitate a smooth transition. These one-time incentives can vary widely based on candidate experience and organizational needs.

Total Compensation Outlook

When combining base salary, bonuses, equity, and other incentives, total annual compensation for this role can range from approximately $180,000 to $350,000 or more in leading firms. Exceptional candidates with specialized FDA combination product expertise and leadership skills may command higher packages.

How to Apply

If you are a seasoned regulatory expert with proven success in managing FDA combination product submissions and shaping regulatory strategy, we encourage you to apply for the Chief Regulatory Strategist – FDA Combination Product Submissions position in Washington, DC. This is a unique opportunity to lead regulatory initiatives that will directly impact innovative healthcare products and market access.

To apply, please submit your updated resume along with a cover letter highlighting your experience with FDA regulatory pathways for combination products, your leadership in regulatory strategy, and your ability to navigate complex compliance environments. Be sure to emphasize your track record of successful submissions, collaboration with cross-functional teams, and your strategic approach to regulatory challenges.

This role offers a high-impact career path where you will play a central role in advancing product approvals and ensuring compliance in a fast-evolving regulatory landscape. Apply today to elevate your career as a Chief Regulatory Strategist and drive the future of combination product development and submission!

For more information or to explore similar regulatory leadership opportunities, please visit our Executive Search for Regulatory Affairs in Combination Products page.

Job Category: FDA Combination Product Submissions

Job Type: Full Time

Job Location: Washington

Chief Regulatory Strategist – FDA Combination Product Submissions | Washington, DC