Open Positions

Senior Regulatory Affairs Manager — Topix Pharmaceuticals Inc., N. Amityville, New York (Hybrid)

Responsible for ensuring compliance with all regulatory requirements of various agencies including Food and Drug Administration, Environmental Protection Agency, Federal Trade Commission, State Boards of Pharmacy and export/import regulations. This includes registration in various countries and issuance of required documents such as NAFTA certificates for Canada and Mexico. Secures international product registrations and maintains all of the associated files, filings, certificates, testing and compliance governing overseas sales. Specific duties include:

• Coordinating regulatory inquiries whether they are official (governmental) or internal.
• Organization of overseas portfolio documents.
• Coordination and ownership of required regulatory filings, testing and communication.
• Oversight of the creation of Product Information Files (PIFs) containing safety information, etc. for each product.
• Regulatory record ownership, oversight and filing.
• Direct consultants, registry agents and responsible parties.
• Procurement of export permits and clearances.
• Primary responsibility for all required product testing.
• Reviewing ingredient statements, formulas and batch records to ensure they meet with all regulatory requirements.
• Responsible for owning and administering all progress dashboards and trackers.
• Responsible party for all registration related communications, both internal and external.
• Approval and administration of costs and budgeting for export related costs.
• Providing regulatory guidance during New Product Development process, including information on ingredient and claims limitations.
• Oversight and supervision of the domestic regulatory manager and assistant.
• Overseas 501K and other device and drug registration.
• Complete all tasks assigned to them by the SVP, R&D.

Please note that this position has supervisory authority over two employees but does not have managerial or hire/fire authority.

Requirements:

Position requires a Bachelor’s degree (or an equivalent foreign degree) in Pharmacy Administration, Regulatory Affairs or a closely related field and 2 years of experience as a Regulatory Affairs Specialist in the pharmaceutical or cosmetics sector. Must also have 2 years of experience (which can have been gained concurrently with the primary experience requirement above) working with the following:

• Gathering information required for registrations in the U.S., Canada and the EU;
• Preparing regulatory filings including for China, the EU and Japan and maintaining complete, audit-ready regulatory files and trackers across product portfolios;
• Providing regulatory guidance during the New Product Development process;
• Leading interactions and negotiations with regulatory authorities;
• Determine and manage the process of obtaining chemical and physical analyses and clinical data to support approval of registrations; and
• Approving labels, reviewing formulas and claims for regulatory compliance.

This is a hybrid position working 1 day each week at the office in North Amityville, NY and 4 days each week at a home office.

Salary is $111,000 to $116,000 per year for a 40-hour work week.

How to apply: Interested applicants can send in your resume to resumes@TopixSkinHealth.com and use job reference “RA2026” in the subject line of the email.