[Hiring] Regulatory Affairs Manager @Clinglobal Group
Role Description
This role drives regional regulatory strategy for Veterinary Medicinal Products (VMPs), ensuring compliance and supporting successful product development, approval, and lifecycle management.
• 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.
Qualifications
• 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.
Requirements
• This is a remote position with potential for regular travel.
• Applicants must be aware that Internet Explorer is not compatible with BambooHire.
• The Company complies with local and international data protection and privacy legislation.
• As part of the hiring process, candidates need to willingly take part in personality and behaviour assessments.
• The Company may perform criminal and/or other relevant checks on all applicants applying for this position.
Benefits
• Compensation: $65,000 - $80,000
This role drives regional regulatory strategy for Veterinary Medicinal Products (VMPs), ensuring compliance and supporting successful product development, approval, and lifecycle management.
• 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.
Qualifications
• 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.
Requirements
• This is a remote position with potential for regular travel.
• Applicants must be aware that Internet Explorer is not compatible with BambooHire.
• The Company complies with local and international data protection and privacy legislation.
• As part of the hiring process, candidates need to willingly take part in personality and behaviour assessments.
• The Company may perform criminal and/or other relevant checks on all applicants applying for this position.
Benefits
• Compensation: $65,000 - $80,000