Vice President, CMC Regulatory Affairs

The posting, as Loyal wrote it

About Loyal

Loyal is a clinical stage veterinary medicine company developing longevity drugs for dogs. Our mission is to help dogs live longer, healthier lives.

We're pioneering a new category of veterinary prescription drugs that proactively and preventatively target the underlying drivers of aging, delaying the onset of disease and preserving quality of life as dogs age. We've already made significant progress toward our first regulatory approvals, with additional submissions targeted in the near future.

Loyal is a well-funded startup . You'll help us continue our path of earning regulatory approval for the first lifespan extension medicine for any species and change what's possible for the dogs we love.

About the role

Loyal is seeking a Vice President, CMC Regulatory Affairs to lead the strategy and operations across all the CMC regulatory activities. This leader will own the full CMC regulatory program across Loyal's pipeline, from early development through approval and into post approval lifecycle management.

A strong CMC regulatory background is essential. The ideal candidate brings deep expertise in small molecule drug development, ideally from human health, with a proven track record leading CMC regulatory teams, executing successful agency interactions, and bringing products to approval. Demonstrated experience in post approval regulatory activities is required.

This role requires both strategic vision and operational execution. The successful candidate will build and lead a regulatory organization capable of supporting Loyal across all stages of development and into a commercial company and will serve as the primary regulatory authority and the company's primary interface with regulatory agencies globally.

The role reports to senior executive leadership and partners closely with leadership across TechOps, Quality, Clinical, Operations, and Commercial.

Your daily work will include

• Own and drive Loyal's overall CMC regulatory strategy across all active programs, aligned with development milestones and commercial objectives, from early development through approval and post approval lifecycle management.
• Provide CMC regulatory input into portfolio planning, program prioritization, and business development activities, ensuring regulatory feasibility and risk are embedded in key decisions.
• Develop and maintain global regulatory intelligence capabilities, monitoring evolving agency expectations, guidance documents, and industry precedents relevant to Loyal's programs and translating these into actionable strategies.
• Provide regular CMC regulatory updates and risk assessments to executive leadership and the board on submission progress, agency interactions, and regulatory risk.
• Lead all CMC regulatory activities including filing strategy, CMC section authorship and review, post approval CMC change management, and regulatory oversight of manufacturing and CDMO partners.
• Ensure CMC regulatory strategy reflects curr

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opportunity employer. We do not discriminate against applicants based on gender, race or color, ethnicity or national origin, age, disability, religion, sexual orientation, gender identity or expression, veteran status, or any other applicable characteristics protected by law.

Our values

Moonshots, derisked methodically

Bringing the first longevity drug to market is an extremely difficult technical and social pursuit. To achieve this, we must take bigger bets than the field has historically made, paired with the technical rigor to de-risk them step by step. We plan on both short and extremely long timescales, and we have the conviction to see our vision through to success or failure.

Opportunity is at the intersection

We lean into combining disciplines, expertise, and perspectives not normally adjacent. We design our organization to facilitate cross-pollination and cross-collaboration. We reject silos.

Expertise without ego

Titles do not determine who has a voice. We push back on each other, ask questions instead of issuing orders, and try to prove ourselves wrong. We are emotionally attached to the outcome, not our personal hypotheses, and welcome being challenged instead of treating it as a threat.

High agency, high humility

Most of what we're doing has never been done before, so we can't rely on established precedents to guide our way. We move forward to generating clarity, build strategies resilient to the fact that we don't know what we don't know, and design small experiments where we can fail safely, without jeopardizing the bigger mission.

Lead with transparency and context

We proactively and consistently share the why behind our strategy - not just the what - because we believe sharing context enables great people to make great decisions.

Empathy and respect for all life

Our patients are not just numbers. We deeply respect the value of every life, large and small and take our ethical responsibility to the families we treat extremely seriously.