Executive Director, Regulatory Strategy EU/ROW
Category: Research & Development | Country: United Kingdom | City: Oxford | Type: Regular, Full Time | Job ID: 4265
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
The Europe & Rest of World Regulatory Strategy Leader is a key leadership position within the Global Regulatory Affairs organization; this role is responsible for providing strategic expertise and leadership to the molecule Global Regulatory Leaders (GRLs) and Global Expansion Leader from pre-clinical strategy through filings in non-major markets.
This leader is responsible for the company’s regulatory affairs Europe and Rest of World product strategies working in collaboration with the Global Regulatory Leaders. He / she will advise and collaborate with the global regulatory teams during target product profile development, clinical development design, labeling development and negotiations, and promotional regulatory affairs to ensure the best strategies and plans to obtain worldwide approvals to market our products and provide ongoing regulatory support for our development and commercial products. He / she may be required to attend Global Regulatory Affairs as senior regulatory leadership at health agency meetings but will not take the place of the Global Regulatory Leader / Global Expansion Leader at those meetings unless specifically requested prior to the interaction.
This role has Europe and Rest of World responsibilities, which includes global stakeholders, participation in global teams and interaction with regulatory agencies in multiple regions, including the United States. This role may have line management responsibilities. This role will be a member of the Global Regulatory Leadership Team, European Management Team (EMT) and the European Medical Affairs Leadership Team (EMALT).
Strategic Partner of the Global Regulatory Team and Global Expansion Team:
- Represents EU/RoW Regulatory Strategy as a member of the Global Regulatory Team (GRT). Responsible for ensuring collaboration with Global Regulatory Leaders and Global Expansion Leader to ensure successful planning and execution of the global regulatory strategy for assigned program(s) with future plans of being marketed outside the United States.
- Accountable for advising the team in the development and maintenance of a global regulatory strategy plan in conjunction with the GRL and EU Strategy Lead, to ensure that relevant input is vetted and included in the regulatory strategy in order to deliver on the Target Product Profile (TPP), regional specific needs, regulatory environment, regulatory risks and mitigations, and global submission strategies.
- Identify and assess regulatory risks associated with product development and recommend strategies to mitigate risks.
- Ensure appropriate representation of regulatory affairs on key internal program/project teams. Ensure strategic regulatory input is provided to key development activities and documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans
- Shaping and executing regulatory strategies against overall portfolio development and lifecycle management strategy in collaboration with the Regional Marketing, Access and Medical team as well as with the Global Molecule Team in collaboration with the Global Regulatory Lead.
- Play a lead role with the European Management Team (EMT) as well as the European Medical Affairs Leadership Team (EMALT) in helping shape and impact their market strategies and tactics
- Serve as leader and spokesperson with European and Rest of World Regulatory Authorities and industry trade associations (e.g. EUCOPE)
- Oversee compliance and adherence to regulations and applicable guidelines for all EU/RoW regulatory activities as well as being the Regulatory Affairs point of contact during EU/RoW inspections.
- Minimizes company risk through conducting risk assessments and recommendations for various regulatory scenarios
Manages staff and contributes to the development of regulatory professionals and leaders:
- Attracts and retains talent
- Coaches, trains and mentors staff and leaders, thereby contributing to successful global regulatory strategies and submissions
- Accountable for ensuring appropriate support for the European and Rest of World Regulatory Affairs including forecasting, budgeting, resource planning and resource allocation
Responsible for establishing, developing and maintaining collaborative relationships with European and Rest of World regulatory affairs vendors and contractors, including affiliate regulatory affairs vendors and contractors, to ensure effective, productive and professional working relationships
- Accountable for vendor selection, agreements, work orders, contracts, purchase orders, and approving invoices.
- Negotiates with vendor to determine roles, responsibilities, processes and mutual expectations.
- Responsible for vendor oversight and governance.
Required Knowledge, Skills, and Abilities
- Proven track record of experience in Global Regulatory Affairs, including a minimum of 8 years’ experience in drug development and registration activities; prior experience in relevant therapeutic area strongly preferred
- Experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies
- Thorough knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in the European Union, Japan and other agencies around the world.
- Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.
- Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities
- Prior line management experience in Europe.
- Excellent verbal and written communication skills and collaborative interpersonal skills.
Other Valuable Experience:
- Ability to think strategically; demonstrated negotiating skills and resourcefulness.
- Strong interpersonal skills; proven track record of staff management and effective leadership.
- Demonstrated ability to manage several projects simultaneously.
- Strong influencing skills, able to lead without formal authority.
- High degree of influencing skills in shaping and developing content and wording.
- Demonstrated ability to work collaboratively; multicultural sensitivity, builds positive and productive relationships, seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions / proposals.
- Can manage uncertainty and shifting priorities and timelines.
- Demonstrates learning agility.
- Demonstrated ability to make decisions even in the absence of complete information.
- Excellent organizational and time management skills.
- Demonstrated track record of driving performance and leadership ability within a team environment
- Ability to consistently balance the needs of commercial strategy, drug development, and regulatory compliance
- Proven track record of effective collaboration with the EMA and/or other regulatory agencies globally in gaining pharmaceutical product approvals and defending established products
Required/Preferred Education and Licenses
- Bachelors or Masters or advanced degree in a scientific discipline
Description of Physical Demands
- Responsibilities may require working outside of “normal” hours, in order to meet business demands.
Jazz Pharmaceuticals is an Equal Opportunity Employer.