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.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.
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