Regulatory Project Manager
- Reporting to the Global Head of Regulatory Affairs, the Regulatory Project Manager (RPM) is a dynamic Regulatory Affairs professional responsible for leading the end-to-end planning, coordination, and execution of regulatory deliverables for the assigned project(s)
- The RPM contributes to regulatory submission strategy, identifying submission risks and opportunities, whilst leading simple or complex regulatory applications and managing procedures through to regulatory approval.
- The RPM provides regulatory guidance to the Global cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives to support SOTIO’s growing portfolio and assets over the course of the clinical development.
- The candidate will have primary responsibility for activities pertaining to regulatory strategy and submissions in Europe and US.
- The successful candidate will be a good communicator with a can-do attitude and the ability to effectively collaborate across functions and with external collaborators
Key Activities and Responsibilities
- Develop innovative strategies to address the regulatory requirements for the allocated program(s) under the supervision of the Global Head of Regulatory Affairs
- Provide regulatory guidance to multidisciplinary teams to support nonclinical and clinical development of allocated asset(s)
- Critically review and provide strategic input on study related documents (e.g., Investigator’s Brochure, clinical protocol amongst others)
- Lead multidisciplinary teams (either independently or in collaboration with regulatory CRO) in the development and authoring of major regulatory documentation such as Briefing Package, orphan designation, paediatric plans, BLA/MAA modules amongst others.
- Develop, execute and maintain submission delivery plans and proactively provide status updates
- Lead and facilitate activities, including team preparation, for meetings with FDA, EMA, and other regulatory agencies
- Act as an interface with global regulatory agencies and consultants as needed
- Guide the cross functional team and keep an oversight on the CRO regulatory activities through the preparation and maintenance of IND and EU CTA submissions
- Lead the CTA / IND Response team activities
- Ensure compliance of all regulatory activities including compliance with regulatory procedures and work practices
- Develop and implement regulatory operating guidelines/SOPs and common work practices/strategies within the regulatory team
- Support compliance activities, including development and update of internal trainings and SOPs
- Understand the regulatory framework, including regional trends, for various types of applications and procedures focusing primarily on Europe and the US.
- Act as a regulatory intelligence partner to be able to leverage and benefit from the latest regulatory tools
- Demonstrate a learning and development mindset while sharing learnings along the way as the company continues to grow
- Contribute to the development, structure and success of the regulatory department as well the overall organization
Qualification and Requirements
- Education: Pharmacist or Life Science degree
- Fluent in English
- Minimum 3 years of regulatory experience within the biopharmaceutical industry
- General knowledge of drug development
- Good project management skills
- Leadership skills, including experience leading multi-disciplinary project teams internally and contracted personnel such as regulatory representatives at CROs
- Strong expertise in EU regulatory requirements with a good understanding of the US regulation
- Demonstrated experience in the preparation and submission of INDs, CTAs, new indications (BLA/MAA as a plus)
- Detail oriented with concise written and verbal communication skills
- Strategic thinker, planner with good organizational skills
- Strong critical and logical thinking with ability to analyze and propose solutions to problems
- Ability to multi-task together with an ability to prioritize
- Highly motivated with a team spirit and able to function independently
- Good computer proficiency (MS Word, Excel, PowerPoint, Adobe Acrobat etc)
- Travel to Health Authority or across the global company’s sites will be expected up to 25% max
- Basel (Switzerland), in the Sotio offices based on the Novartis Campus
In addition to CV, please attach a cover letter.