Regulatory Affairs Manager Opportunity
We are seeking a highly motivated and experienced Regulatory Affairs Manager to join our growing team. This is a fantastic opportunity to make a tangible impact within a dynamic business that prioritises performance and offers excellent career progression.
As the Regulatory Affairs Manager, you will play a crucial role in ensuring our diverse product portfolio complies with global regulatory frameworks. This is a hands-on management position where you will be expected to drive results.
Key Responsibilities:
* Developing and implementing robust regulatory strategies to support product development and lifecycle management.
* Leading and mentoring a team of Regulatory Affairs Officers, fostering a collaborative and high-performing environment.
* Efficiently integrating all new portfolio acquisitions across multiple international markets.
* Spearheading projects to identify and resolve gaps in regulatory dossiers.
* Leading high-level meetings with Regulatory Authorities.
* Driving the regulatory aspects of internationalizing products and pursuing reclassification when appropriate.
* Proactively monitoring and interpreting global regulatory trends and changes, ensuring we are always ahead of the curve.
What We Are Looking For:
Our ideal candidate will be a resilient and adaptable individual with a strong sense of ownership and a proven track record in regulatory affairs. Essential experience and knowledge include:
* 8-10 years of progressive experience in Regulatory Affairs within the pharmaceutical industry (human health)
* Strong knowledge of global regulatory frameworks, including MRP, DCP, and CP procedures
* Demonstrable experience with pharmaceutical products, specifically OTC and/or prescription medicines, with a focus on preparing and submitting dossiers for multiple EU countries
* A proactive attitude with a strong drive to see tasks through to conclusion
* Exceptional attention to detail and outstanding organisational skills
* Ability to work autonomously, take initiative, and assume responsibility for your actions
What's On Offer:
* Competitive Salary: A highly competitive salary, negotiable based on experience
* Performance-Based Bonuses: Your hard work and contributions will be recognised and rewarded through performance-based bonuses
* Hybrid Working: A flexible working model to offer flexibility while fostering team collaboration
* Career Progression: Opportunities for professional development and career advancement within the company are significant