Director, GRA CMC Pharmaceuticals, Oligonucleotides
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Job Description
About 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 a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals regulatory team in the development and implementation of global CMC regulatory strategies during development commercialization and post approval LCM stages. Combine knowledge of scientific, regulatory and business issues to ensure the regulatory filings are of high quality and right first time. Maintain up-to-date knowledge and expertise of relevant CMC and quality guidelines and regulations and establishes mechanisms to communicate them to relevant stakeholders, thereby driving prospective and proactive implementation.
You will also globally influence and be generally considered a key opinion leader and resource within Takeda and externally with stakeholders in HA and in Industry. Influence changing regulations and guidance documents; interfaces with outside regulatory agencies and trade associations and acts as an advisor/liaison to senior management to plan, evaluate and recommend implementation strategy. Establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives.
As part of the GRA CMC Pharmaceuticals, Oligonucleotides team, you will report to the Executive Director and Head, CMC Regulatory Affairs, Pharmaceuticals.
How you will contribute:
- Responsible for demonstrating Takeda leadership behaviors. Serve as a member of the GRA-CMC Pharmaceuticals Leadership team, giving input to key strategic, portfolio, human capital and financial decisions.
- Provide leadership of GRA CMC Pharmaceuticals “ modality, and in conjunction with direct reports, manages resources, establish a CMC RA strategy and collaborate with stakeholders in global Reg CMC and across the enterprise to deliver against them.
- In conjunction with members of the team, develop high quality clinical, commercialization and LCM submissions, using proactive regulatory CMC strategies and submit them as planned.
- Build and manage relationships through active partnering with key internal (GRA, GRA CMC, Pharmaceutical Sciences, GMS, GQ etc.) and external stakeholders (Health authorities, Industry counterparts/associations, academia). Relationship management and constructive partnering with Health Authorities and relevant industry organizations to drive Takeda position and influence scientific approach and thought process to CMC topics.
- Ensure team effectiveness in working across a very complex matrix environment in GRA with CMC RA project leads and other GRA sub-functions, as needed to ensure effective strategies are developed and project execution is on target.
- Build and maintain communication strategy and platform for all staff across the organization. Responsible for timely dissemination of regulations, guidelines and data to staff and stakeholders via team sites or intranet. Actively engage and influence organization to think proactively and utilize science and risk based approach to product development and LCM activities.
- Contribute to creating and communicating an employment culture and values which attract, retain, and develop the most effective people.
- Ensure compliance with all applicable Takeda SOPs, local and international regulations, and industry best-practice.
- Represent, as required, the regulatory function in the evaluation of new product opportunities internally and externally.
- Lead or plays a key role on the relevant internal Takeda governance
- committees
Minimum Requirements/
Qualifications:
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 10
years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience strongly preferred. - Experience liaising with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams.
- Ability to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Demonstrated leadership, problem-solving ability, flexibility and teamwork.
- Good judgement in elevating and communicating actual or potential issues to line management.
- Experience of active participation in Agency/Industry groups/forums expected.
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.
This position is currently classified as hybrid in accordance with Takeda's Hybrid and Remote Work policy.
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EEO Statement
Takeda 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.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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Estimated Salary: $20 to $28 per hour based on qualifications.
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