Regulatory Affairs Specialist

An opportunity has arisen for a Regulatory Affairs Specialist to join a globally recognized leader in St. Louis. This role offers you the chance to make a meaningful impact by ensuring that products meet all regulatory requirements across multiple regions. You will be part of a supportive and knowledgeable team that values your expertise, encourages professional growth, and provides flexible working opportunities to help you balance your career with your personal life.

Key Responsibilities:

As a Regulatory Affairs Specialist, you will play an integral role in guiding products through complex regulatory landscapes from initial submission through post-approval maintenance. Your day-to-day responsibilities will involve preparing detailed submission dossiers tailored to specific local requirements, managing communications with authorities, and ensuring all feedback is addressed promptly. You will keep internal teams informed about progress on key milestones and provide valuable strategic input during the development of new products. In addition to supporting the expansion of existing product lines into new markets, you will also be responsible for monitoring evolving regulations and advising on potential impacts or opportunities. By coordinating agency consultations and developing robust action plans, you will ensure that all submissions are managed efficiently and compliantly. Your efforts will directly contribute to the successful launch and ongoing compliance of vital health solutions worldwide.

• Compile submission dossiers according to local regulatory requirements, ensuring accuracy and completeness for timely approvals.
• Manage the entire submissions procedure and maintain effective interactions with regulatory authorities to facilitate smooth processes.
• Organize feedback responses to authorities within established deadlines, maintaining clear communication throughout each stage.
• Provide regular updates to internal stakeholders regarding key milestones, expected approval dates, and strategic regulatory input for new development programs.
• Support geo-extension activities for existing products as well as manage the full regulatory lifecycle of marketing authorizations across various regions.
• Establish recommendations on regulatory feasibility and participate actively in go/no-go decision-making processes for new projects.
• Develop and agree upon comprehensive regulatory action plans to oversee new submissions and ongoing compliance activities.
• Coordinate agency consultations efficiently, ensuring all necessary documentation and information are prepared in advance.
• Monitor changes in regulations through proactive regulatory watch activities, providing insightful recommendations on opportunities and risks for product portfolios.
• Obtain new marketing authorizations while maintaining existing ones in strict compliance with relevant regional regulations.

Key Requirements:

To excel as a Regulatory Affairs Specialist, you will bring substantial experience navigating complex regulatory frameworks within the pharmaceutical or health industries. Your background should include hands-on involvement with dossier preparation, project management across multiple jurisdictions, and direct interaction with both internal teams and external authorities. You are adept at balancing multiple priorities while maintaining meticulous attention to detail under tight timelines. Your interpersonal skills enable you to communicate clearly with colleagues at all levels, fostering collaboration across departments. A proactive approach towards monitoring industry trends ensures you remain ahead of emerging challenges or opportunities. Your commitment to continuous learning aligns perfectly with an organization that values professional development and encourages employees to expand their skillsets. Ultimately, your expertise will help drive successful outcomes for critical projects that support animal health worldwide.

• Demonstrated experience compiling complex regulatory submission dossiers in accordance with local or international requirements within the pharmaceutical or health sector.
• Proven ability to manage end-to-end submissions procedures while maintaining effective communication with regulatory authorities.
• Strong organizational skills with experience responding promptly to authority feedback within tight deadlines.
• Excellent stakeholder engagement abilities, including providing clear updates on project milestones and offering strategic input for development programs.
• Experience supporting geo-extension initiatives and managing the full lifecycle of marketing authorizations across multiple regions or countries.
• Sound judgment in establishing recommendations on regulatory feasibility and participating constructively in go/no-go decisions for new projects.
• Ability to develop comprehensive action plans for new submissions as well as ongoing compliance activities within regulated environments.
• Skilled at coordinating agency consultations by preparing thorough documentation and facilitating productive discussions with external bodies.
• Up-to-date knowledge of changing regulations through active participation in regulatory watch activities; able to assess risks and opportunities effectively for product portfolios.
• Track record of obtaining new marketing authorizations while maintaining existing ones in compliance with diverse regional regulations.

What sets this company apart:

This organization stands out as a pioneer in health thanks to its unwavering dedication to both employee well-being and environmental responsibility. Employees benefit from a unique culture that prioritize trust-based partnerships between managers and staff, encouraging open dialogue and mutual respect at every level. The company’s commitment to internal mobility means you can explore diverse roles or even international assignments as your career evolves. Individual development plans are crafted collaboratively so that each team member receives personalized support tailored to their aspirations. Flexible working arrangements allow you to maintain a healthy work-life balance while pursuing professional excellence. The company’s focus on nurturing talent extends beyond technical training—employees are empowered to acquire new skills that prepare them for tomorrow’s challenges while contributing meaningfully today. By joining this team, you become part of an inclusive community united by shared values: compassion for animals, dedication to responsible business practices, and enthusiasm for making a positive impact on global health outcomes.

What's next:

If you are ready to take your expertise in regulatory affairs to the next level within an inspiring environment focused on growth and collaboration, this is your moment!

If interested in this position, please contact Kate Treacher at +1 512 610 6264 or Kate.Treacher@robertwalters.com