Regulatory Strategic Partnership Lead - United States
- We put our heart, soul and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation. Will you join us in this pioneering adventure?
- For the assigned portfolio of products, the Regulatory Strategic Partnership Lead provides global regulatory strategic and operational expertise to business, affiliates, external partners and relevant key internal stakeholders to ensure qualitative and timely execution of regulatory plans in support of business and compliance needs.
- The role will Lead, manage and provide support for all regulatory deliverables, project management activities, internal interface interactions, governance board data packages, as well as the supportive external alliance partner activities. Critical responsibilities include, but are not limited to:
- Acts as the primary regulatory contact person with FDA or EMA on behalf of our company for the assigned portfolio
- In collaboration with the strategic partner and Global Regulatory Leadership, manages development of regulatory strategies that maximize regulatory opportunities over the product life-cycle.
- Acts as the primary interface between Patient Value Units (PVUs), Patient Value Operations (PVO), other internal stakeholders, and the Regulatory strategic partner during the development and implementation of Global Strategic Regulatory Plans.
- Applies knowledge of regulatory requirements, guidance and precedence across different geographic areas and leads regulatory teams to obtain successful outcomes to execute regulatory strategy and drive regulatory compliance on the assigned portfolio.
- Bachelor’s degree in the life sciences (preferred) is required. Advanced degree (MS, Ph.D. JD) preferred.
- 6+ years relevant work experience in a multicultural, matrix and global pharmaceutical environment including relevant experience in Global Regulatory strategy and submissions management and interacting with key Global Health Authorities Excellent understanding of the pharmaceutical industry and the drug development process, including global/regional regulatory requirements and industry standards.
- Relevant experience in working with, supporting or liaising with (Regulatory) contract organizations
- Experience working in a global cross-functional environment, understanding complexities and interconnectivity
- Excellent project leadership and project management skills (including data analyses, synthesizing and reporting); identifies opportunities to improve project and process efficiencies, is results oriented and proactively takes action to move activities forward with appropriate sense of urgency
- Strong communication skills (both verbal and written, incl. presentation skills).
- Proven ability to communicate and collaborate effectively with senior management and business stakeholders from very diverse parts within and outside of the organization.
- Overnight travel, including international, may be required.
- Our company is a global biopharmaceutical company.
- We focus on discovering and developing innovative medicines and lateral solutions that can transform the everyday lives of people living with severe disease.
- With more than 7500 people in approximately 40 countries, our company offers an exciting working environment where initiative can flourish and those with a ‘can-do’ attitude can thrive. Thinking holistically, working together, championing change, delivering impactful results…these are some of the key competencies we are constantly developing, and looking for, at our company.
- Our company and its subsidiaries encourage diversity in the workplace; we are an Equal Opportunity Employer. Minority/Female/Disability/Veteran
Job Segment: Regulatory Affairs, Law, Pharmaceutical, Legal, Science, Strategy, Research