Director, Regulatory Strategy (Remote)

Job Description

Job Description

The Director, Regulatory Strategy is a key leadership role responsible for developing, implementing, and managing regulatory strategies to support Immuneering’s business objectives, product development, and future global market access. This individual will serve as a subject matter expert, working with cross-functional teams and executive leadership through complex regulatory environments, ensuring compliance with all applicable laws, standards, and industry best practices.

• Regulatory Strategy Development: Lead the creation and execution of comprehensive regulatory strategies for new products, markets, and business initiatives, ensuring alignment with organizational goals.
• Compliance Oversight: Monitor and interpret evolving regulatory requirements at local, national, and international levels; ensure the organization remains compliant and proactively address potential regulatory risks.
• Cross-Functional Leadership: Collaborate with R&D, clinical, legal, pre-commercial, and quality teams to integrate regulatory considerations into business planning and decision-making.
• Regulatory Submissions: Oversee the preparation, review, and submission of regulatory documents and applications to relevant authorities, including FDA, EMA, and other global agencies.
• Stakeholder Engagement: Serve as a key regulatory contact for internal and external stakeholders, including regulatory agencies, industry associations, and strategic partners.
• Team work: work within a team comprised of consultant regulatory professionals and full time staff fostering a culture of excellence, collaboration, and continuous learning.
• Risk Management: Identify and mitigate regulatory risks that could impact product development timelines, market access, or business operations.

Qualifications

• Advanced degree in life sciences, pharmacy, law, or related field (PhD, PharmD, JD, or equivalent preferred).
• Minimum 8+ years of progressive regulatory experience in the pharmaceutical, biotechnology, medical device, or healthcare industry.
• Demonstrated experience in developing and executing global regulatory strategies, including successful interactions with major regulatory agencies.
• Proven leadership skills, with experience managing and developing high-performing teams.
• Excellent communication, negotiation, and interpersonal skills.
• Strong analytical, strategic thinking, and problem-solving abilities.
• Must live the values of being: All In, Caring, Data Driven, Own It (accountable) & Humble
• Ability to work in a fast-paced, dynamic environment and manage multiple priorities.

Education

• Advanced degree in life sciences, pharmacy, law, or related field (PhD, PharmD, JD, or equivalent preferred)

Technical / Soft Skills

• Must live the values of being: All In, Caring, Data Driven, Own It (accountable) & Humble
• Ability to work in a fast-paced, dynamic environment and manage multiple priorities.

Preferred Skills

• Expert knowledge of FDA, EMA, and other global regulatory frameworks.
• Experience with regulatory submissions for innovative products and therapies.
• Track record of successful regulatory approvals and market launches.
• Experience in policy advocacy and external stakeholder engagement.
• Multinational or multi-region regulatory experience.

Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission.

Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam.

Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.