This opportunity is available in both Palo Alto, CA and Philadelphia, PA.
This position is a key leadership position leading the Global Regulatory Affairs (GRA) department. This role is responsible for setting the vision and multi-year organizational strategy for Global Regulatory Affairs and drives execution ensuring actions and deliverables are of quality standards, on-time, and within budget, while achieving required compliance.
- Provides risk assessments and recommendations for various regulatory scenarios.
- Defines and executes regulatory strategies against overall portfolio development and lifecycle management strategy in collaboration with the Commercial, Clinical, Technical Operations, Finance and Legal teams as well as with the R&D executive leadership of Jazz Pharmaceuticals.
- Supports GRA strategy leaders in effective interactions with global health authorities and when necessary leads health authority interactions.
- Ensures all regulatory submissions including original marketing applications, clinical trial applications, amendments, supplements, and variations, responses to health authorities’ questions, meeting requests, briefing packages, annual reports, periodic safety reports, etc. are prepared to the highest quality and submitted in a timely manner.
- Ensures compliance and adherence to regulations and applicable guidelines for all regulatory submissions
- Manages resources to ensure that approvals are timely and development objectives are met including workforce planning and resource allocation decisions for department. Holds leaders accountable to deliver department objectives within budget.
- Coach and mentor Global Regulatory Affairs staff including direct reports ensuring appropriate levels of accountability for delivering according to Jazz core competencies and values, and clearly communicate across Jazz.
- Active member and participant of the R&D leadership team collaborating with other members to ensure corporate objectives and R&D objectives are aligned, and that the GRA department is delivering on its strategic objectives.
- Occasionally interacts with executive management. Interactions are usually related to high priority regulatory deliverables or objectives.
- Measure performance of department through defined performance, quality and compliance metrics.
Required Knowledge, Skills, and Abilities
- Education with a minimum of 15 years of regulatory experience
- Highly self-motivated and comfortable operating in an entrepreneurial and decentralized environment
- A demonstrated track record of driving performance and leadership ability within a team environment
- Demonstrated ability to attract, build and motivate a regulatory team of high-functioning individuals
- Highly resilient and achievement-oriented, with the ability to succeed in an environment that demands fast but well-founded decision-making on a vast number of multidisciplinary issues
- Demonstrated ability to consistently balance the needs of commercial strategy, drug development, and regulatory compliance
- Proven track record of effective collaboration with regulatory agencies globally in gaining pharmaceutical product approvals and defending established products
- Exceptional written and verbal communication skills
Required/Preferred Education and Licenses
- Undergraduate degree required in life science or management; Graduate degree preferred.
Description of Physical Demands
- Occasional mobility within office environment.
- Routinely sitting for extended periods of time.
- Constantly operating a computer, printer, telephone and other similar office machinery.
Description of Work Environment
- Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
- Frequent computer use at workstation.
- May move from one work location to another occasionally.
- Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
Occasional public contact requiring appropriate business apparel.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.