Senior Manager, Regulatory Affairs US & Canada Strategy Lead Therapeutic Neurotoxins

Location: Hybrid in Florham Park, New Jersey, United States

Salary: $124,500–$236,500 per year

Company

hirify.global develops innovative medicines and healthcare solutions across areas including immunology, oncology, neuroscience, and aesthetics.

What you will do

• Develop and implement US and Canada regulatory strategic and tactical plans for marketed and developing therapeutic neurotoxin products.
• Support regulatory strategy execution with Global Regulatory Leads and cross-functional project teams.
• Act as a Health Authority liaison, including coordinating FDA meetings, briefing packages, and responses.
• Prepare and review regulatory submissions and support product approval, commercialization, and registration maintenance.
• Advise Public Affairs, Clinical Development, Legal, Commercial, and other internal stakeholders on regulatory issues.
• Make independent decisions on cross-functional project matters and contribute to junior staff training.

Requirements

• Advanced degree such as PharmD, PhD, or MS, or regulatory certification.
• At least 5 years of Regulatory, R&D, or equivalent industry experience.
• Experience implementing affiliate regulatory strategies, preferably in the US or Canada.
• Experience working with government regulatory agencies and in complex matrix environments.
• Strong negotiation, problem-solving, written communication, oral communication, and consensus-building skills.
• Ability to interpret US and Canada regulations, guidance, and corporate policies.

Nice to have

• Direct experience with pharmaceutical regulatory activities.
• Global regulatory experience.

Culture & Benefits

• Paid vacation, holidays, and sick leave.
• Medical, dental, and vision insurance for eligible employees.
• 401(k) benefits for eligible employees.
• Eligibility to participate in long-term incentive programs.
• Work in a cross-functional, complex, and matrix environment.