Director, CMC Regulatory ComplianceMultiple Locations
- Job Type: Full Time
- Job Level: Senior
- Travel: Minimal (if any)
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.
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, CMC Regulatory Compliance employee
How you will contribute:
- The Director of CMC Regulatory Compliance is responsible for the strategic and operational activities pertaining to global and local compliance within Global Regulatory Affairs – Chemistry, Manufacturing and Controls & Devices (GRA CMC).
- Partners and influences cross functionally with colleagues in Quality Assurance, Compliance, Global Manufacturing and Supply, Pharmaceutical Sciences, Global Regulatory Operations, and Local Operating Companies to drive compliance and continuous improvement.
- Leads and manages Compliance and QMS operational activities (QE, CAPA, GxP Training, etc.) and is a point of contact for Regulatory CMC on audits & Inspections
- Develops and manages a program for the tracking, execution, monitoring, and reporting on GRA CMC processes (Metrics and KPIs) to drive excellence in Regulatory CMC pre and post submission activities.
- Seeks opportunities to build optimized CMC capabilities through digital solutions and automation enablement for optimal execution and compliance.
- Ensure Regulatory CMC is aligned with and responsive to health authority regulations and guidelines as they pertain to requirements for drugs, biologics, combination products and devices.
- Collaborates across Global Regulatory CMC to ensure clear and timely communication about compliance risks, business processes, compliance activities and metrics.
- Partner with CMC LT to support global strategic CMC initiatives related to pre and post submission activities and the processes and systems used to manage compliance.
- Independently manages oversight of all Compliance and QMS operational activities (QE, CAPA, GxP Training, etc.) and a robust compliance metrics review program.
- Ensure CMC inspection readiness and act as a main point of contact with Global Quality and other stakeholders for internal and external audits
- Ensure that responses resulting from audit and inspection findings and CAPAs related to GRA CMC are aligned with CMC LT and stakeholders.
- Ensure GRA CMC Commitments (i.e. IND, post marketing) and Quality Events are managed within specified timelines.
- Build effective relationships with GRA Compliance and other R&D Compliance departments to develop new and updated end-to-end processes for execution of GRA pre and post submission activities.
- Escalate issues/problems to CMC LT as needed and propose risk-based remediation actions for consideration
- Provide input on budgets for the group as appropriate
- Maintain strong knowledge of current regulations, legislation, best practices, and guidelines relating to Regulatory CMC.
CORE ELEMENTS RELATED TO THIS ROLE
- This role is best suited for someone with proven management experience of staff as well as influence in a matrix structure.
- Process minded and analytical thinker with demonstrated experience applying risk management principles when implementing compliance solutions.
- Knowledge of the pre and post submission regulatory requirements on major markets like EU, USA, Canada, U.K. and other international markets.
- Operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment.
- This role is global and has cross-functional collaboration across multiple parts of the Regulatory, Quality and R&D groups including TAU, MPG, Business Units, and CROs.
- Quality System Management and Regulatory drug development experience are key for this role to be successful.
- Systems Knowledge – knowledge of Quality Management Systems including Deviation and CAPA management, SharePoint, and Regulatory Information Management (RIM).
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Regulatory knowledge of European, US and international regulations relative to pre and post submission regulatory requirements.
- Industry Knowledge – strong understanding of the pharmaceutical industry and pharmaceutical companies’ operations processes and strategies particularly Quality Management Systems, Drug Development, Regulatory Affairs, and Compliance.
- Demonstrated ability to work independently to inspire, motivate, and lead people across functions, regions, and cultures.
- Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
- Proven skills as an effective team player who can engender credibility and confidence within and outside the company
- Ability to distil complex issues and ideas down to simple comprehensible terms
- Demonstrates leadership presence and confidence
- Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
- Invests time in helping others to enhance their skills and perform at a higher level
Decision-Making and Autonomy
- Provide input to complex decisions that impact Regulatory CMC
- Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
- Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution
- Responsible for providing input to and implementing vision and strategy for Regulatory CMC
- Effectively navigates the changing external and internal environment and helps lead others through change
- Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
- Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions
- Strategic thinking with the ability to recommend and implement innovative continuous improvement solutions, particularly with automation.
- Comfortable challenging the status quo and bringing forward innovative solutions
- Ability to put forth risk based innovative solutions enhancing CMC Compliance, accelerating time to market, business process efficiencies, etc.
- Identifies opportunities and anticipates changes in the business landscape through a deep understanding of the environment affecting the business and active engagement with relevant cross functional stakeholders
- Ability to work effectively in a global ecosystem (internal and external) with a high degree of complexity
- Must be able to lead and participate in cross-functional and cross regional teams and deliver results on behalf of CMC
- Ability to understand the broader, enterprise level perspective when assessing issues and implementing solutions
- Bachelor’s degree (or equivalent) required. Masters preferred.
- 10 plus years’ experience in pharmaceutical industry, with direct Regulatory CMC experience.
- Direct exposure in QA and/or a Compliance function within the drug development lifecycle a plus.
- Experience with Health Authority inspections and audits.
- Knowledge of Global Regulatory Affairs function and the key interactions of GRA necessary to achieve goals and objectives.
- Ability to identify and measure risk of non-compliance and recommend business process changes in a complex environment.
- Knowledge of global health authority regulations for pre and post submission activities
- Practical operational experience of working across disciplines and across multiple regions. Experience working within a global team framework and a multi-cultural environment.
- Able to manage both time and priority constraints and to manage multiple priorities independently.
- Capability to critically analyze complex and/or ambiguous information and the impact on products and process.
- Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
- RAPS Regulatory Affairs Certification (RAC) a plus.
What 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.
This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.
Base Salary Range: $156,800- $224,000 based on the candidate's professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off.
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
Empowering our people to shine:
Takeda is proud of 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.
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.
LocationsBoston, MAZurich, Switzerland
Time TypeFull time
The heart of our work
Shining a light on new perspectives
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.
Working at Takeda
InclusionHere, you will feel welcomed, respected, and valued as a vital contributor to our global team.
CollaborationA strong, borderless team, we strive together towards our priorities and inspiring mission.
InnovationBold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top WorkplaceRecognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Work-LifeOur people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
EmpowermentThrough trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
Create an exceptional people experience.
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
Jobs for you
- Global Regulatory Affairs CMC Internship - Summer 2024 Boston, Massachusetts Category: Intern/trainee/apprentice
- GRA Compliance QMS Summer Intern 2024 Boston, Massachusetts, Remote Category: Intern/trainee/apprentice
- Director, GRA CMC Small Molecules Boston, Massachusetts Category: Regulatory Affairs
- Executive Director and Head, CMC Regulatory Affairs - Biologics Boston, Massachusetts Category: Regulatory Affairs
Join our talent community
Get customized job alerts sent right to your inbox. Plus, get the latest in company news and other important resources by signing up for our talent community.