Global Regulatory Strategy Director

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide regulatory leadership for Enveda's assets from Phase 2 onward.

• Create innovative global regulatory strategies for Enveda's clinical development and life-cycle management portfolio.

• Oversee the preparation of regulatory submissions, which include INDs, CTx, briefing documents, IB, NDA, DMF, and IMPD.

• Identify gaps in submissions and develop strategies to mitigate risks.

• Act as Enveda's representative with global health authorities and lead interactions with these agencies.

• Serve as the subject matter expert for Regulatory Affairs on cross-functional teams.

• Provide regulatory guidance and oversight to global project teams.

• Ensure that regulatory activities align with health authority requirements.

• Coordinate and uphold health authority reporting schedules.

• Keep track of the regulatory landscape and inform leadership about health authority initiatives and their impacts.

• Lead, mentor, and develop global regulatory teams.

• Establish Regulatory Affairs policies, SOPs, and work instructions.

• Advise cross-functional teams on the implementation of AI for regulatory dossiers.

⛳️ Requirements

• Bachelor's degree in a scientific field.

• A minimum of 12 years of experience in Regulatory Affairs within the pharmaceutical or biotech sector.

• Proficient negotiation skills with health authorities, including the FDA, EMA, and Health Canada.

• Experience with submissions from IND/CTx through to NDA or marketing applications.

• Background in developing and executing regulatory strategies for oral small-molecule programs.

• Exceptional oral, written, and presentation skills, including experience presenting to leadership teams.

• Proven organizational awareness and experience in cross-functional representation.

• Outstanding planning and organizational abilities, capable of managing multiple projects under tight deadlines.

• Strong knowledge of regulatory operational activities.

• A self-starter with an entrepreneurial mindset, adaptable and proactive in responding to changing business needs and priorities.

• A pragmatic, compliant, and solution-oriented approach.

🏝️ Benefits

• Equal opportunity employer.

• Diversity-valuing workplace.