Identify continuous improvement opportunities Develop guardrails for other departments to ensure that international regulatory compliance is met and maintained Partner cross-functionally with Marketing, Supply Chain, Brand Management, Legal, and Sales.

Responsible for providing regulatory strategic support for global regulatory activities for innovative biologics throughout the lifecycle of the product (IND/CTAs, NDAs/BLAs, Marketing applications.

We are seeking an International Export and Regulatory Affairs Manager to join Primal and own product compliance, food safety and international regulatory for our business both in North America and Internationally.

This role will provide CMC regulatory support and guidance for assigned projects and interfaces with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest quality to meet global health authority expectations.

As a vital member of the Food Safety and Quality Assurance team, you will provide essential support for Sales & Marketing, Purchasing, and Product Development. Program Management: Oversee HACCP, SSOP, SPS, allergen management, and labeling programs, ensuring compliance with USDFSIS and internal food safety regulations.

Manage the strategy, negotiation, and provisions of the GRADS (inclusive of Regulatory Affairs, Labeling, REMS, Regulatory Operations, CMC, Medical Safety including PV Operations EUQPPV Office) components of the Master Commercial Agreements with external partners involving but not limited to product acquisitions, collaborations, distribution, co-marketing, co-promotion, joint ventures, and divestitures.

Represent regulatory CMC on and/or lead matrix teams for small molecule pipeline products and/or commercial products through completion of post-marketing commitments and relevant lifecycle management projects driven by research.

You will report to the SVP, Global QA, RA & ESG and work closely with colleagues from R&D, Product Management & Marketing, QA&RA and other functions, to plan and perform regulatory submissions, product registrations/listings and renewals towards FDA, Health Canada and other Regulatory Authorities, in collaboration with subject matter experts and regulatory service providers.

Adheres to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.

Hands on experience on authoring CMC documentation for worldwide marketing of Veterinary products for initial registration and life-cycle management. Lead development and execution of global product and project regulatory, strategy(ies) for assigned Veterinary products in accordance with global regulations and guidance.

Over 10 years related experience in product development and regulatory strategy, and/or regulatory affairs, with a minimum of 3 years in combination product area. The Senior Director of Regulatory Affairs, Specialty Pharma, will be responsible for leading regulatory strategy for specialty pharma products, especially combination products in development and life cycle management, including A/NDA products and biosimilars.

Budget Management – Skilled at planning and managing the budget necessary to support regulatory affairs activities. Lead and direct the activities of the code and regulatory affairs and product compliance teams.

Provide guidance and advise management regarding improvement in CMC harmonization process of regulatory documentation at all manufacturing sites. Provide regulatory guidance to R&,D, Technical Operations Sales and Marketing, Quality, Clinical, Legal.

Risk Management and Mitigation: Identify and assess regulatory risks associated with product development and commercialization. Cross-Functional Collaboration: Collaborate with cross-functional teams, including R&D, quality assurance, clinical, and marketing, to ensure regulatory requirements are integrated into product development and commercialization processes.

Work closely with Business Unit Leaders, Global Sales, and Product Marketing to ensure NPD launch planning, and Global registration renewal are in alignment with business priorities. Responsible for the administration of the Regulatory Affairs Management Software tool.