Global Regulatory Strategy Director

Enveda

3d•$220,000 - $250,000•Remote

About The Position

As Global Regulatory Strategy Director at Enveda, you will lead the development and execution of regulatory strategies for a pipeline of first-in-class small-molecule medicines. You will serve as the regulatory subject matter expert for global project teams and lead Enveda’s interactions with health authorities worldwide. In your first year, you will shape global registrational strategies and lead supporting submissions, influencing the company’s regulatory strategy and clinical pipeline.

Requirements

Bachelor’s degree in a scientific discipline.
At least 12 years of Regulatory Affairs experience in pharma or biotech.
Strong health-authority negotiation skills, including experience with agencies such as FDA, EMA, and Health Canada.
Regulatory submission experience from IND/CTx through NDA or marketing applications.
Excellent oral, written, and presentation skills, including experience presenting to leadership teams.
Demonstrated organizational awareness, including experience representing Regulatory Affairs cross-functionally and on global teams.
Excellent planning and organizational skills, with the ability to manage multiple projects and tight timelines in a fast-paced, hands-on environment.
Strong understanding of regulatory operational activities.
Self-starter with an entrepreneurial spirit who is flexible and proactive in adapting to changing business needs and priorities.
Pragmatic, compliant, and solution-oriented mindset.

Nice To Haves

Advanced degree such as an MS, PharmD, or PhD.
Experience across all phases of development.
Experience developing and executing regulatory strategies for oral small-molecule programs.
Experience in obesity or dermatology.

Responsibilities

Provide regulatory leadership for Enveda’s assets through Phase 2 and beyond, and lead development of global registrational strategies.
Develop global regulatory strategies for the clinical-development portfolio and lifecycle management with minimal supervision.
Lead regulatory submissions, including INDs, CTx, briefing documents, IBs, NDAs, DMFs, and IMPDs; identify gaps and develop risk-mitigation strategies.
Represent Enveda in interactions with global health authorities and lead agency engagements to achieve company objectives.
Represent Regulatory Affairs as the subject matter expert on cross-functional teams, providing regulatory guidance and oversight to global project teams.
Ensure regulatory activities comply with health-authority requirements and coordinate and maintain reporting schedules with cross-functional teams.
Monitor the regulatory landscape and inform leadership about health-authority initiatives and their impact on Enveda’s programs.
Lead global regulatory teams, mentor and develop regulatory colleagues, and support Regulatory Affairs senior leadership as needed.
Lead the development of Regulatory Affairs policies, SOPs, and work instructions.
Guide cross-functional teams on implementing AI for regulatory dossiers.