Director of Regulatory Affairs – CMC

AL Solutions; United States; Remote; USD 250,000 - 280,000; Full time

Job summary

A rapidly expanding life sciences consultancy is seeking a fully remote Director of Regulatory Affairs – CMC to lead regulatory strategy and execution. Ideal for a U.S.-based regulatory expert, the role offers strategic oversight in a fast-paced environment focused on biologics and RNA therapies, with competitive compensation and flexible working arrangements.

Benefits

401(k)

Medical insurance

Vision insurance

Flexible working structure

Above-market salary

Performance-based bonuses

Qualifications

• 10+ years of experience in Regulatory Affairs, focusing on CMC and biologics.
• Experience with U.S. and global regulatory submissions, including INDs and BLAs.
• Strong knowledge of FDA/EMA requirements for novel modalities.

Responsibilities

• Lead end-to-end CMC regulatory strategy for U.S. and global submissions.
• Act as the primary regulatory contact for clients and manage Health Authority interactions.
• Mentor junior regulatory professionals and support team expansion.

Skills

Regulatory Affairs

CMC

Stakeholder Management

Communication

Education

Advanced degree in life sciences

Job description

Direct message the job poster from AL Solutions

Expert in connecting top Regulatory Affairs & C-suite talent with Biotech, CRO, and Pharmaceutical clients across Europe and the US.

A rapidly expanding and innovation-driven life sciences consultancy is seeking a Director of Regulatory Affairs – CMC to lead regulatory strategy and execution across a high-impact portfolio of biologics and RNA-based therapeutics, including mRNA, gene-modified cell therapies, and ATMPs.

This fully remote leadership opportunity is ideal for a seasoned, U.S.-based regulatory expert who thrives in a fast-paced, client-facing environment and is eager to play a central role in shaping regulatory pathways for novel therapies.

Key Responsibilities:

• Lead end-to-end CMC regulatory strategy for U.S. and global submissions (INDs, IMPDs, BLAs, MAAs, variations).
• Act as the primary regulatory contact for biotech clients and serve as the point person for Health Authority interactions, including FDA and EMA.
• Provide strategic guidance on RNA-based platforms, biologics manufacturing, comparability, and post-approval changes.
• Collaborate closely with cross-functional client teams (CMC, QA, clinical, nonclinical) to ensure alignment on global regulatory requirements.
• Support regulatory content development, risk assessments, and technical documentation in alignment with evolving guidelines.
• Drive regulatory intelligence efforts and contribute to thought leadership within the consultancy.
• Mentor and develop junior regulatory professionals; support hiring and team expansion as needed.

Your Profile:

• 10+ years of Regulatory Affairs experience with a strong focus on CMC and biologics; RNA-based therapeutic experience highly desirable.
• Demonstrated success leading U.S. and global regulatory submissions, including INDs and BLAs.
• Strong knowledge of FDA/EMA requirements and regulatory expectations for novel modalities.
• Prior experience in a consulting, biotech, or CRO environment preferred.
• Exceptional stakeholder management, communication, and client-facing skills.
• Must be based in the U.S., preferably in Eastern or Central time zones to optimize collaboration.
• Advanced degree in life sciences or related field preferred.

What’s On Offer:

• Director-level leadership with strategic oversight across breakthrough therapeutic areas.
• Fully remote, flexible working structure tailored to work-life balance and productivity.
• Opportunity to influence pioneering biotech programs in RNA, mRNA, and gene-modified therapies.
• Work with some of the most innovative biotech companies in the U.S. and EU markets.
• Competitive compensation, above-market salary, performance-based bonuses, and long-term career growth.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research

• Industries

  Research Services, Biotechnology Research, and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at AL Solutions by 2x

Inferred from the description for this job

401(k)

Medical insurance

Vision insurance

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