Labeling reputed company Director

Job Title: Labeling reputed company Director

Job Location: Durham, reputed company Carolina, reputed company of America

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

The Role:

reputed company is seeking a Director of Regulatory Labeling reputed company to support new programs to be based in the US. This role is intended for a reputed company looking, creative regulatory reputed company reputed company to anticipate and address the challenges involved in reputed company delivering labeling for new products for global markets, including the reputed company, European reputed company, the United Kingdom and Switzerland. This is a 6 month contract with the potential for extension.

RESPONSIBILITIES

• Global labeling experience to reputed company labeling reputed company support across labeling for CCDS, US, EU, Rest of World (ROW), and other major markets.
• reputed company and maintain reputed company knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed.
• reputed company the reputed company Product Label (TPL) development for early-phase assets.
• reputed company labeling content, format and accountability for regulatory submissions (MAAs) and reputed company 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.
• reputed company with Project Teams to ensure consistency of labeling processes and local compliance with CCDS.
• Effectively communicate the regulatory labeling reputed company, risks, mitigation strategies and overall plans to the Global Regulatory Science Leadership Team, Project Development Teams and senior management, as relevant.
• reputed company input to the end-to-end labeling process.
• Ability to reputed company and manage labeling team meetings, driving strategic discussions and managing content.
• reputed company coverage, as needed, on other products during peak periods or during absences of other team members.

SPECIFIC SKILLS

• Experience facilitating meetings and driving reputed company 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.
• reputed company of urgency regarding FDA/EMA/reputed company/other HA communications and response timelines to reputed company coverage for product approvals and labeling negotiations.
• reputed company: overriding commitment to reputed company and high standards for self and others.
• Results orientation
• Strategic orientation: ability to reputed company 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 reputed company parties.
• Flexibility/adaptability: ability to adapt to, and work effectively reputed company, a reputed company of situations and with various individuals and reputed company.
• 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 reputed company global regulations, including specifically: e.g. vaccine development regulations and registrations reputed company.
• Strong experience with CTD format and content regulatory filings
• Exceptional written and oral communication
• Experience dealing with broad reputed company of stakeholders at reputed company reputed company reputed company to reputed company
• Delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA, etc.)

reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at

reputed company is proud to be an equal opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law.

reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company 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 reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.

reputed company is a talent-hiring platform in Life Sciences, reputed company and IT. The platform connects talent with opportunities in reputed company, biotech, health sciences, healthtech and IT domains.

Please apply reputed company reputed company platform to get connected to the application page and to reputed company similar roles.

Originally posted on Himalayas