The Role:
IQVIA is seeking a Director of Regulatory Labeling Strategy to support new programs to be based in the US. This role is intended for a forward looking, creative regulatory professional able to anticipate and address the challenges involved in swiftly delivering labeling for new products for global markets, including the United States, European Union, the United Kingdom and Switzerland. This is a 6 month contract with the potential for extension.
RESPONSIBILITIES
- Global labeling experience to provide labeling strategy support across labeling for CCDS, US, EU, Rest of World (ROW), and other major markets.
- Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed.
- Lead the Target Product Label (TPL) development for early-phase assets.
- Develop labeling content, format and accountability for regulatory submissions (MAAs) and related supplements and amendments. Ensure that new labeling text meets regulatory labeling requirements.
- Support the project teams with Rest of World ROW labeling assessments against the CCDS and preparation of Health Authority (HA) responses.
- Interface with Project Teams to ensure consistency of labeling processes and local compliance with CCDS.
- Effectively communicate the regulatory labeling strategy, risks, mitigation strategies and overall plans to the Global Regulatory Science Leadership Team, Project Development Teams and senior management, as relevant.
- Provide input to the end-to-end labeling process.
- Ability to lead and manage labeling team meetings, driving strategic discussions and managing content.
- Provide coverage, as needed, on other products during peak periods or during absences of other team members.
SPECIFIC SKILLS
- Experience facilitating meetings and driving consensus and results.
- Excellent leadership, communication (verbal and written) and collaboration skills.
- Proven ability in medical/technical writing.
- Labeling experience (CCDS, US, EU, UK, other major markets) in rare diseases, oncology and/or vaccines is desirable.
- Experience with TPL work for early development programs and identified life-cycle programs.
- Sense of urgency regarding FDA/EMA/MHRA/other HA communications and response timelines to provide coverage for product approvals and labeling negotiations.
- Integrity: overriding commitment to integrity and high standards for self and others.
- Results orientation
- Strategic orientation: ability to link company and departmental visions with daily work
- Interacts effectively as member of the Regulatory sub-team, communicating effectively on strategies to the Global Labeling Committee and collaborating with business partners, including affiliates and third parties.
- Flexibility/adaptability: ability to adapt to, and work effectively within, a variety of situations and with various individuals and groups.
- Relationship building, teamwork and cooperation: builds and maintains strong working relationships with colleagues.
QUALIFICATIONS
- BA/BS degree in a scientific discipline required, Master’s or PhD preferred.
- 10+ years of experience in the pharmaceutical industry
- 7+ years of experience in Regulatory labeling
- Strong knowledge of current global regulations, including specifically: e.g. vaccine development regulations and registrations pathways.
- Strong experience with CTD format and content regulatory filings
- Exceptional written and oral communication
- Experience dealing with broad range of stakeholders at all levels internal and external to the company
- Delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA, etc.)
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $128,800.00 - $358,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.