Job Summary
We are seeking a seasoned professional to lead our Commercial Regulatory Affairs and Business Operations team in Europe. As a Senior Director, you will play a key role in ensuring the efficient and compliant operation of the regulatory affairs department, with a focus on collaborating with cross-functional teams to drive business objectives.
This is an exceptional opportunity for a highly experienced individual with a strong understanding of European regulatory requirements and processes related to promotion and commercialization. You will have excellent organizational skills, leadership abilities, and the capacity to work effectively in a matrixed environment.
Key responsibilities include leading the European MLR process, managing regulatory activities through vendor selection and management, providing training and guidance to internal teams, and overseeing local regulatory policy changes and their impact on business operations.
Responsibilities
* Advertising and Promotional Activities: Ensure timely and compliant regulatory review of promotional and non-promotional materials in Europe.
* Training and Guidance: Provide training and guidance to internal teams on regulatory requirements and best practices for promotional activities and other activities as required.
* Oversight of Local Regulatory Activities: Develop and oversee local regulatory activities through vendor selection, management, and serve as the primary liaison between the central regulatory affairs team and local regulatory vendors.
* Cross-Functional Collaboration: Work closely with internal departments, including Pharmacovigilance, Quality Assurance, Commercial, and Medical teams, to ensure regulatory activities are conducted timely and compliantly.
* Regulatory Compliance: Ensure all regulatory activities are conducted in compliance with applicable regulations and guidelines, maintaining up-to-date knowledge of regulatory requirements in each country's jurisdiction.
Requirements
* Seasoned professional with a minimum of 12 years of relevant experience with solid expertise and knowledge of applicable European regulatory regulations, directives, and guidelines.
* Strong experience understanding of European regulatory requirements, particularly concerning promotional activities.
* Must have experience dealing with regulatory representatives in EU countries.
* Must have solid understanding of quality and GxP standards.
* Excellent communication and leadership skills.
Benefits
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers.
What We Offer
* A dynamic and collaborative work environment.
* Opportunities for growth and professional development.
* A comprehensive benefits package.