Associate Director CMC Regulatory Compliance

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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 an Associate Director, CMC Regulatory Compliance employee

How you will contribute:

• The Associate Director, 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 (GRA CMC).
• Partners with cross functional 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.
• Builds and maintains optimized CMC capabilities through digital solutions and automation enablement for optimal execution and compliance.

ACCOUNTABILITIES

• Ensure Takeda CMC is aligned and responsive to health authority regulations and guidelines as they pertain to applicable regulatory requirements for drugs, biologics, combination products and devices.
• Collaborates across Global Regulatory CMC to ensure clear and timely communication about 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.
• Manages oversight of all Compliance and QMS operational activities (QE, CAPA, GxP Training, etc.) and a robust compliance metrics review program
• Leads and ensures CMC inspection readiness and main point of contact with Global Quality and other stakeholders for internal and external audits
  • Ensures a state of CMC inspection readiness
  • Coordinates CMC documentation and information requests prior to, during and in follow up to inspections/audits
  • Supports the development of responses and CAPAs related to GRA CMC for audits/inspections
• Ensures GRA CMC Commitments (i.e. IND, post marketing) and Quality Events are documented and tracked in the appropriate systems
• 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 senior management as needed and propose risk-based remediation actions for consideration
• Provides input on budgets for the group as appropriate
• Maintains 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 process minded and analytical thinkers who know how to apply risk management when implementing compliance solutions that are effective and sustainable
• Working knowledge of the pre and post submission regulatory requirements on major markets like EU, USA, Canada, U.K. and other international markets.
• Practical 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 Familiarity – 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.

Leadership

• Demonstrated ability to lead people across functions, regions, and cultures
• Demonstrated ability to excel in a team environment with the ability to inspire and motivate and drive to results
• 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

Interaction

• 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

Innovation

• Strategic thinking with the ability to recommend and implement continuous improvement and innovative 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

Complexity

• 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

Minimum Requirements/Qualifications:

• Bachelor’s degree (or equivalent) required.  Masters preferred.
• 8 plus years’ experience in pharmaceutical industry, with good exposure to QA, and/or Compliance, and Regulatory Affairs, .
• Familiarity with inspections and audit procedures and able to work with QA leads who host Takeda audits and inspections.
• Knowledge of Global Regulatory business area and key interactions and ability to identify the interactions necessary for achieving business goals and objectives
• Ability to identify and measure risk of non-compliance and adjust to 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 simultaneously
• Capability to critically analyze complex and/or ambiguous information and the impact on products and process and to effectively communicate complex issues both verbally and in writing
• Excellent analytical, technical and problem-solving skills (Auditing, TQM or Six Sigma experience preferred).
• 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: $137,200 to $196,000 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.

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.

Boston, MA

Zurich, Switzerland

Employee

Regular

Full time

About the Company:
Takeda Pharmaceutical

Salary : $137,200 - $196,000