At a Glance
- Tasks: Lead regulatory strategies for innovative diabetes treatments and ensure compliance with local regulations.
- Company: Proclinical, a dynamic company focused on cutting-edge healthcare solutions.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Mentorship opportunities and a commitment to continuous improvement.
- Why this job: Make a real impact in the healthcare industry while collaborating with diverse teams.
- Qualifications: Advanced degree in science or equivalent experience in regulatory affairs required.
The predicted salary is between 60000 - 80000 £ per year.
Be the strategic force behind bringing cutting-edge diabetes treatments to market. Proclinical is seeking a Senior Regulatory Scientist to provide strategic regulatory leadership and oversight for assigned products within the diabetes therapy area. In this role, you will be responsible for aligning local regulatory strategies with global objectives, ensuring compliance with regional regulations, and leading interactions with regulatory authorities. This position offers an opportunity to make a significant impact on product development, approval, and lifecycle management in a dynamic and collaborative environment.
Responsibilities
- Develop and implement local regulatory strategies aligned with global plans for assigned products.
- Lead the preparation, submission, and approval of high-quality regulatory documents, including local labeling and packaging.
- Manage relationships and lead interactions with regional regulatory authorities, influencing outcomes to support business objectives.
- Provide regulatory expertise to cross-functional teams, ensuring compliance with local and regional requirements.
- Monitor and interpret evolving regulatory guidelines, initiating changes as needed to maintain compliance.
- Support clinical trial registration needs for local patients in the region.
- Collaborate with global regulatory leads to address development and regulatory challenges.
- Participate in regional meetings to align regulatory strategies with commercial and medical needs.
- Mentor and guide team members, fostering an inclusive and innovative work environment.
- Contribute to continuous improvement initiatives to enhance efficiency and productivity.
Qualifications
- Advanced scientific degree (e.g., PhD, MD, PharmD) or equivalent experience in regulatory affairs or drug development.
- Strong knowledge of local and regional regulatory procedures and practices.
- Demonstrated ability to navigate complex regulatory environments and manage risk effectively.
- Excellent written, verbal, and presentation communication skills.
- Proven negotiation and influencing abilities.
- Attention to detail and a commitment to quality.
- Experience in medical device or in-vitro diagnostics regulatory activities is a plus.
- Ability to work collaboratively across diverse teams and embrace equity and inclusion.
Senior Regulatory Scientist in Bracknell employer: Proclinical Group
Proclinical is an exceptional employer that fosters a dynamic and collaborative work environment, perfect for those looking to make a meaningful impact in the field of diabetes treatment. With a strong commitment to employee growth, Proclinical offers opportunities for mentorship and continuous improvement initiatives, ensuring that every team member can thrive and contribute to innovative regulatory strategies. Located in a vibrant area, the company promotes a culture of inclusivity and equity, making it an attractive place for professionals dedicated to advancing healthcare solutions.
