Senior Director, Global Regulatory Affairs CMC
Senior Director, Global Regulatory Affairs CMCJob ID R0086824 Date posted Mar. 10, 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 a Senior Director, Global Regulatory Affairs CMC where you are accountable for the development and execution of regulatory CMC risk strategy. You will manage staff members. As part of the Global Regulatory Affairs CMC team, you will work with Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff.
How you will contribute:
Combines the knowledge of scientific, technical, regulatory, and business issues to drive and execute global product strategy throughout the development and commercial lifecycle.
Demonstrate Takeda leadership behaviors.
Globally influences and is considered a key opinion leader within Takeda and externally.
Participate in global teams that require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance.
Influences changing regulations and guidance, interfaces with outside regulatory agencies and trade associations, and acts as an advisor/liaison to senior management to plan, evaluate and recommend a regulatory strategy.
Ensures team effectiveness in a complex matrix environment.
Able to deal with issues of critical importance provide regulatory advice and make reasoned decisions for which there may not be clear/specific regulatory guidance.
Demonstrates Takeda leadership behaviors in leadership, problem-solving ability, flexibility, and teamwork.
Quick to adapt strategies based on regulatory and business need changes.
Acts as CMC regulatory expert for developing regulatory advice on complex topics and sharing with influence to global project teams/task forces.
Builds and manages relationships through active partnering with key internal and external stakeholders.
Lead and contribute to department and business process improvements.
Evaluate new business development opportunities or represent Global Regulatory Affairs CMC on due diligence teams.
Ensure that project team colleagues, line management, and partners are informed of developments, risks, and opportunities that may weigh on regulatory success.
Elevate and clearly communicate actual or potential issues to stakeholders and management.
Demonstrated track record for successful interactions with FDA and other global health authorities related to CMC submissions.
Represent Takeda Global Regulatory Affairs CMC in Health Authority meetings and lead CMC preparation activities for meetings with Health Authorities on CMC-related matters.
Significant staff management experience for staff professional development, as well as leading submission teams for marketing applications, clinical trial applications, and life cycle management.
What you bring to Takeda:
BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
15+ years of pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience, strongly preferred.
proven experience liaising with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred.
Expert 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.
Provides regulatory advice and is able to make/communicate difficult decisions.
Demonstrated leadership, problem-solving ability, flexibility, and teamwork.
Excellent judgment in elevating and communicating actual or potential issues to line management.
Excellent written and oral communication skills.
Experience of active participation in Agency/Industry groups/forums expected.
Willingness to travel to various meetings, including overnight trips.
Requires approximately up to 10-30% travel.
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.
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