Senior Manager/Associate Director, CMC Regulatory Compliance, GRA Chemistry, Manufacturing and Controls (GRA CMC) - Now Hiring

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OBJECTIVES/PURPOSE

• The Senior Manager/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 Global Quality, Global Manufacturing and Supply, Pharmaceutical Sciences, Global Regulatory Operations, Local Operating Companies and other stakeholders for successful CMC regulatory compliance management.
• Develops and manages a program for the tracking, execution, monitoring, and reporting on GRA CMC processes and responsibilities to drive excellence in Regulatory pre and post submission activities.

ACCOUNTABILITIES

• Collaborates with Global Regulatory CMC leadership to ensure clear and timely communication about compliance activities and metrics.
• Responsible for alignment with global strategic CMC initiatives related to pre and post submission activities and the processes and systems used to manage compliance.
• Development and leadership of the following activities at a global level in collaboration with relevant partners:
  • Responsible for compliance-relevant strategic initiative activities which may impact GRA CMC compliance of pre and post submission activities.
  • With GRA Compliance and GRA CMC SMEs, as relevant, develops new and updated processes for execution of GRA pre and post submission activities.
• Ensure Takeda is aligned and responsive to health authority regulations and guidelines as they pertain to applicable regulatory requirements for drugs, biologics, combination products and devices.
• Provides support to Global Quality and other stakeholders for internal and external audits:
  • Ensures CMC inspection readiness
  • Coordinates CMC documentation 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, PIP) and Quality Events are documented and tracked in the appropriate systems
• 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 Affairs and GxP.

CORE ELEMENTS RELATED TO THIS ROLE

• Extensive 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 (Trackwise) systems, SharePoint, and Regulatory Information Management (RIM).

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Regulatory Familiarity – extensive 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 Regulatory Affairs processes and the Regulatory Compliance function.

Leadership

• Demonstrated ability to work across functions, regions and cultures
• Functional level leadership with the ability to inspire, motivate and drive 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
• Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.
• Invests time in helping others to enhance their skills and perform at a higher level

Decision-Making and Autonomy

• Decision making responsibilities:
  • Provide input to highly complex decisions that impact the functional area
  • Ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/synthesize and communicate to internal/external stakeholders
  • 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 
• Accountable for providing input to and implementing vision and strategy for designated scope

Interaction

• Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
• 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

• Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation
• Comfortable challenging the status quo and bringing forward innovative solutions
• Ability to take risks implementing innovative solutions, accelerating time to market
• Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.

Complexity

• Ability to work in a global ecosystem (internal and external) with a high degree of complexity
• Must be able to lead cross-functional and cross regional teams and deliver results in a matrix organization
• Ability to see and understand broader, enterprise level perspective.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

• Bachelor’s degree (or equivalent) required.  Masters preferred.
• 8 plus years’ experience in pharmaceutical industry, with good exposure to Regulatory Affairs, QA, and/or Compliance.
• Familiarity with inspections and audit procedures and able to work with QA leads who host Takeda audits and inspections.
• Strong knowledge of Regulatory business area and interactions and ability to identify the interactions necessary for achieving business goals and objectives
• Ability to identify proactively and anticipate risk of non-compliance in a complex environment
• Demonstrated 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 (TQM or Six Sigma experience preferred).
• Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
• Personnel management experience.
• RAPS Regulatory Affairs Certification (RAC) preferred.

Base Salary Range: $124,600 to $178,000, based on candidate 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.   

• In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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.