Regulatory Affairs Manager – Clinaxel, United States of America
Clinaxel is part of a group of Animal Health Contract Research Organizations servicing the global animal health industry.
We are actively recruiting for a Regulatory Affairs Manager based in the United States of America to join our growing Regulatory Affairs team at Clinaxel. This position offers the opportunity to work remotely with the visits at the office situated in Waverley, New York as required. This position reports to our Director: Regulatory Affairs, based in the US.
Primary Job Purpose
This role drives regional regulatory strategy for Veterinary Medicinal Products (VMPs), ensuring compliance and supporting successful product development, approval, and lifecycle management. Key responsibilities include preparing high‑quality regulatory submissions, collaborating with authorities, guiding cross‑functional teams, and navigating regulatory challenges to keep projects on track.
Job Specific Duties and Responsibilities
- Lead regional regulatory activities for Veterinary Medicinal Products (VMPs) and innovation projects.
- Develop and execute effective regulatory strategies in collaboration with cross-functional teams.
- Provide expert guidance on regulatory pathways and support decision-making when challenges arise.
- Prepare, review, and manage high‑quality regulatory submissions, including dossiers, variations, and renewals.
- Coordinate submission documentation and ensure all materials are complete, accurate, and on schedule.
- Build and maintain strong relationships with regulatory authorities, customers, and internal stakeholders.
- Represent the company in key meetings with regional regulatory authorities.
- Monitor regulatory changes, assess their project impact, and communicate actionable insights.
- Identify and mitigate regulatory risks throughout the product lifecycle.
- Partner with R&D and clinical teams to integrate regulatory requirements into development and trial planning.
- Support and improve internal SOPs and regulatory processes to enhance efficiency and compliance.
- Mentor junior regulatory staff and provide regulatory training to internal teams.
- Develop and track a regional regulatory project roadmap, managing timelines and resources effectively.
- Contribute to continuous improvement initiatives within the regulatory affairs function.
Qualification, Training and Experience Requirements
- A Bachelor’s degree in life sciences, pharmacy, veterinary medicine, or a related field is required. Advanced degrees such as a Master’s (MS, MSc), Doctorate (PhD, DVM, MD, PharmD), or equivalent professional qualifications are highly preferred.
- Minimum of five years’ experience in regulatory affairs, project management, or a related field, preferably within the Animal Health, Human Pharma, or Healthcare sectors.
- Strong technical writing and oral presentation skills in English.
- Excellent knowledge and understanding of current industry regulations and applicable local legislation.
- Experience in leading cross-functional teams is a plus.
- Must be willing and able to travel locally and internationally.
Important Note to Applicants
This is a remote position with potential for regular travel.
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The Company complies with local and international data protection and privacy legislation. This includes transparency in the processing of personal information processed about job applicants during the recruitment process. By applying for this position, applicants agree to the processing of their personal data in accordance with our recruitment procedure and Privacy Notice available from our website.
As part of the hiring process, candidates need to willingly take part in personality and behaviour assessments to determine a good fit for the job role. These assessments assist with evaluation of candidates in a fair and thorough manner. All information gathered are kept private and only used to assess suitability for the job role. The Company may perform criminal and/or other relevant checks (as is relevant to the position) on all applicants applying for this position.