Global Regulatory Policy & Innovation - Labeling Lead

Company: Takeda Pharmaceutical
Location: Albrightsville
Posted on: May 27, 2023

Job Description:

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Job DescriptionAbout the role: At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as an Global Regulatory Policy & Innovation - Labeling Lead How you will contribute: You will work Lead and work with regional regulatory affairs experts on a broad set of regulatory policy and innovation initiatives, with a focus on labeling reform and e-labeling. Work closely with GRA-labeling function and product teams to provide real-time therapeutic area and product-specific impact analysis of changes in labeling and product packaging regulations and laws, and partner on global regulatory strategies and objectives. Provide global regulatory intelligence and data-driven insights (with a focus on US and EU regions) regarding product labeling, label compliance, labeling-related competitive intelligence, and other primary research objectives. Coordinate with regulatory compliance function to ensure timely implementation of upcoming and possible regulatory changes for Takeda marketed products Provide strong partnership support and policy insight for a wide range of Takeda regulatory and product functions, including global regulatory product labeling and packaging Lead external engagement strategy for multiple regulatory policy and regulatory science areas, including regulatory product labeling and packaging, electronic labeling pilots, labeling reform, and real world data integration within product labeling. Maintain global visibility and regulatory intelligence regarding developments and opportunities within pharmaceutical product labeling and packaging, among other areas; conduct assessments and provide insights to internal teams as appropriate. Develop and explore innovative strategies for regulatory intelligence, and regulatory innovations regarding data, product labeling, and product development, in coordination with GRPI and GRA stakeholders. Maintain consistent oversight of deliverables. Keep GRA management and all internal customers, partners and stakeholders abreast of progress and provide interim updates on ongoing activities and current initiatives. Ensure issues are escalated when needed and encourage resolution at the appropriate level. Responsible for demonstrating Takeda Leadership Behaviors Minimum Requirements/Qualifications: BS/MS - PhD, JD, MD, or equivalent graduate education strongly preferred. Proven track record working with a major regulatory agency, specific experience in government affairs or policy is preferred but not required. [Director]: A minimum of 10 years of pharmaceutical industry experience. This is inclusive of 8 years regulatory experience or a combination of 10 years regulatory and/or related experience in both development and post-marketing phases. [Associate Director]: A minimum of 5 years of pharmaceutical industry experience. This is inclusive of 3 years regulatory experience or a combination of 5 years regulatory and/or related experience in both development and post-marketing phases. Strong knowledge of regulations and guidance governing drugs and biologics labeling in all phases of development, including post-marketing, in the US and EU, with a good understanding of basic regulatory requirements in other global markets (Japan, China) and emerging markets. Sound knowledge of intelligence tools and methods. Understands and interprets complex scientific issues across projects and therapy area(s) of responsibility as it relates to regulatory requirements, regulatory intelligence, policy and strategy for the region. Excellent collaboration/relationship building, strong influencing and negotiation skills, integrity and adaptability. Outstanding written and oral communication skills as well as managing and adhering to timelines. Proven success at stakeholder engagement across organizational levels and boundaries. Must be strong communicator, and ability to explain complex regulatory issues, trends, and strategies to a wide range of stakeholders Must be strong leader that creates vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff. Experience managing relationships with CROs and/or contractors a plus Takeda can offer you: Comprehensive Healthcare: Medical, Dental, and Vision Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs and company match of charitable contributions Family Planning Support Flexible Work Paths Tuition reimbursement More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. Absent an approved religious or medical reason, all US field-based employees must be fully vaccinated for COVID-19, as a condition of employment.
EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAUSA - DC - WashingtonWorker TypeEmployeeWorker Sub-TypeRegular
Time Type
Full time

Keywords: Takeda Pharmaceutical, Allentown , Global Regulatory Policy & Innovation - Labeling Lead, Other , Albrightsville, Pennsylvania