Regulatory Affairs Lead owning regulatory strategy and safety oversight for assigned products in the Levant. Collaborating with cross - functional teams and ensuring compliance with local and global regulations.
About the role
- Regulatory Affairs Manager at Clinaxel overseeing regulatory strategy for Veterinary Medicinal Products. Leading cross-functional teams and ensuring compliance in product development and approval.
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.
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.
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