Head of Global Promotional Regulatory Affairs and Labeling
11 - 15 years experience • Biotech/Pharma
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 primary scope of the Head of Global Promotional Regulatory Affairs and Labeling is to provide strategic leadership and oversight to Labeling and Advertising/Promotion activities within Jazz, both in the US and abroad. Reporting to the Head of Global Regulatory Affairs, this position works closely with commercial, medical affairs, legal and compliance, corporate affairs, and patient advocacy to ensure external product and disease state communications are both effective and compliant
- Develops and manages a highly competent and technically skilled team responsible for completing activities related to global labeling and regulatory oversight of advertising and promotion for both US and international markets
- Owns/oversees the process (including training), ensures proper governance of risk based decisions and applies regulatory expertise to the review and approval of promotional and other commercial materials (eg, training, disease education)
- Oversees team responsible for delivering strategic content and operational excellence for the development, approval and maintenance of labeling materials, including CCDS’s, Regional/Local labels, and all associated artwork (labels, cartons)
- Represents Global Regulatory Affairs with senior management to provide direction and advice on regulatory issues related to product and disease state communications and product labeling
- Ensures risk based decisions are adequately assessed and/or elevated to senior management according company policies, procedures and established precedents
- Maintains awareness of and communicates with team members regarding changing regulatory agency requirements; provides training and regulatory intelligence to the organization as required
- Through collaboration with other members of global regulatory affairs, ensures the commercial regulatory perspective is considered in the creation of global development plans and related R&D activities
Required Knowledge, Skills, and Abilities
- Highly self-motivated and comfortable operating in an entrepreneurial and decentralized environment
- Broad knowledge of regulations, codes of practice, and associated guidelines pertaining to advertising, promotion and labeling for prescription medicines
- Demonstrated ability to attract, build and motivate a team of high-functioning individuals
- Proven track record of driving performance within a matrixed environment
- Experience directly managing people and/or leadership experience leading global teams, projects, and programs or directing the allocation of resources
- Demonstrated ability to identify emerging issues and initiate actions to recommend solutions, including in areas of ambiguity
- Excellent verbal and written communication skills and collaborative interpersonal skills
Required/Preferred Education and Licenses
- Bachelordegree minimum, Masters, or other advanced degree in a scientific discipline preferred, with a minimum of 10 years of relevant experience in the pharmaceutical industry, including experience in regulatory, legal, compliance, or related disciplines