Associate Director, Clinical Regulatory (Biopharma)

Location: Hybrid in Jersey City, New Jersey, with a minimum of 3 days per week onsite

Salary: $178,000–$215,250 per year, plus bonus and equity compensation

Company

Biopharmaceutical company developing novel treatments through a platform combining chemistry, engineering, computation, biology, and molecular-resolution live-cell microscopy.

What you will do

• Develop and execute global clinical trial application strategies supporting ex-US clinical trial initiations.
• Coordinate preparation, review, submission, and maintenance of regulatory packages and dossier content plans.
• Manage international CTA lifecycles across Europe, the UK, Latin America, Asia Pacific, and other regions.
• Provide regulatory guidance to Study Start-Up, Clinical Operations, Clinical Supply Chain, CMC, and other cross-functional teams.
• Liaise with regulatory agencies and support responses to health authority questions.
• Assess regulatory risks and supervise compliance with quality systems, GCP, and GDPR.

Requirements

• 10+ years of relevant experience with a Bachelor's degree, or 8+ years with a postgraduate degree, preferably in a relevant scientific discipline.
• In-depth knowledge of international and ex-US regulatory requirements, EU-CTR, ICH, and country-specific regulations.
• Experience with submission platforms such as CTIS or IRIS and familiarity with study and GMP documentation required by health authorities.
• Strong communication, negotiation, project management, analytical, problem-solving, and coordination skills.
• Ability to work effectively in a collaborative, cross-functional, fast-paced environment.
• Working knowledge of Veeva, Microsoft Office, Project, and Windows, with strong electronic technical aptitude.

Culture & Benefits

• Collaborative, cross-functional environment in a high-growth biopharmaceutical company.
• 401(k) plan with company matching.
• Medical, dental, and vision insurance with substantial employer premium coverage.
• Mental health and wellness benefits, enhanced parental leave, generous paid time off, and holiday policies.
• Weeklong summer and winter holiday shutdowns, life and AD&D insurance, and subsidized onsite lunches.