Associate Director, Global RA CMC Biologics - Hybrid
Associate Director, Global RA CMC Biologics - HybridJob ID R0106516 Date posted Sep. 19, 2023 Location Boston, Massachusetts
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 to bring life-changing therapies to patients worldwide.
Join Takeda as an Associate Director, Global Regulatory Affairs CMC where you will be responsible and accountable for Regulatory CMC development, registration, and post-approval strategies. You will communicate and negotiate with international Health Authorities, directly and indirectly. You will ensure global strategies are accomplished across both new product development and existing portfolio life cycle management. As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
How you will contribute:
Independently manage regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities.
Member of global teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance.
Recommend direction for essential operations and new programs in collaboration with local and global team members.
Lead team members that establish CMC content (data and documentation) requirements for regulatory submissions and will review this content for conformance with the established requirement.
Develop staff, if required, including staff professional development and project oversight.
Represent Takeda Regulatory Affairs CMC in Health Authority meetings and lead preparation activities for meetings with Health Authorities on CMC-related matters.
Interact directly with international Health Authorities. Participate in and facilitate agency meetings.
Ensure project team colleagues, line management, and partners are informed of developments that may affect regulatory success. Provide solutions to prevent the recurrence of issues.
Stay up-to-date with current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and share experience with others to support their development.
Maintain constructive relations with essential colleagues, e.g. colleagues within Takeda, Alliance Partners, and Health Authority representatives.
Evaluate new business development opportunities or participate in due diligence teams.
Evaluate change proposals for global regulatory impact and plan global variations and amendments.
BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
8+ years of pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
Experience with pharmaceutical development of active pharmaceutical ingredient/drug substances or drug products, analytical characterization, process scale-up, or regulatory registration of products is required.
Experience with global regulatory aspects of CMC involving undefined frameworks with medium technical complexity and defined scope. Experience liaising with Regulatory Agencies having served as lead in successful Agency Interactions related to CMC submissions 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. Provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
Demonstrate leadership, problem-solving ability, flexibility, and values teamwork.
Demonstrated ability to work well within a matrix structure in a complex environment.
Exercise good judgment in elevating and communicating actual or potential issues to line management and present solutions to those issues.
Excellent written and oral communication skills are required.
Active participation in Agency/Industry groups/forums is preferred.
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.
Time TypeFull time
- Job Type Full time
- Job Level Senior
- Travel Minimal
Global Regulatory Affairs (GRA) develops and executes innovative regulatory strategies to provide life-changing therapies to patients. GRA has a strategic role in all stages of global product development and across the Takeda Enterprise.
At Takeda, we strive to provide transformational opportunities for every member of our team, and we empower our people to take charge of their futures. In an environment that fosters lifelong learning and a growth mindset, you’ll have the support you need to thrive — at work and beyond.
- Oversee regulatory activities
- Provide strategic focus
- Collaborate cross functionally
- Ensure regulatory compliance
Where You Fit In
When you join our Regulatory Affairs team, you’ll help ensure the fastest, safest path for our treatments to get to patients. With colleagues who encourage you to question everything for better outcomes, you’ll be part of a team that’s deeply involved across each therapeutic area, from candidate selection to post-marketing.
At Takeda, you’ll join an environment with the energy and flexibility of a start-up. We continue building on our 240-year history as a global biopharmaceutical leader through our innovative mindset and lean governance. Find everything you need on our Regulatory Affairs team to positively impact patients’ lives while taking strides within your own.
Integrity is at the center of everything we do. This value is not something that you teach—it comes with the package.Tatiana Ishida Head of Global Regulatory Affairs, Marketed Products Group and Labeling
We sit outside of the traditional disciplines, so we’re able to get involved in everything. Our role is to distill complex information and pull insights that give us a competitive advantage.Nahid latif Head, Global
Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.Learn More
What We Believe In
Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.
Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.
We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.
Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.
Working at Takeda
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Recognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
View All Regulatory Affairs JobsSearch
Sr. Manager, Global Labeling (REMOTE)
Georgia, Remote Regulatory Affairs Apply for Sr. Manager, Global Labeling (REMOTE)
US Lead, Global Regulatory Policy & Innovation
Boston, Massachusetts, Remote Regulatory Affairs Apply for US Lead, Global Regulatory Policy & Innovation
Director, Global Regulatory Affairs CMC- Cell & Gene Therapy
Boston, Massachusetts, Remote Regulatory Affairs Apply for Director, Global Regulatory Affairs CMC- Cell & Gene Therapy
We Take Action by Focusing on Our Four Priorities
- Create an exceptional people experience
- Responsibly translate science into highly innovative, life-changing medicines and vaccines
- Protect our planet
- Unleash the power of data and digital
Would you like to receive relevant opportunities in your inbox as soon as they’re posted?SIGN UP
Are you interested in company news, attending career events, and hearing more from Takeda?Join