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TakedaPharmaceutical Nordics AB · 6 hours ago

Director, Regulatory Site CMC

Boston, MA

Full-time

Hybrid

Director/Executive

$174K/yr - $274K/yr

10+ years exp

Takeda Pharmaceuticals is a forward-looking R&D organization dedicated to delivering transformative therapies to patients. The Director Regulatory Site CMC will ensure efficient management of regulatory change control and post-approval activities at the site level, supporting diverse modalities and driving standardization and sustainability in regulatory processes.

Pharmaceuticals

Responsibilities

Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements

Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes

Drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities

Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions

Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics

Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations

Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale

Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings

Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact

Promote sustainable practices and scalability in site-level regulatory operations

Qualification

Regulatory CMC experienceGlobal HA requirementsScientific principles understandingLeadership skillsCommunication skillsProblem-solving abilityCollaborationNegotiationTeamworkAttention to detail

Required

BS/BA Degree in a Scientific Discipline, Advanced Degree (M.S., Ph.D., etc.) preferred

10+ years of overall biopharmaceutical/device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required

Strong practical experience with global HA requirements, beyond EU/US

Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support

Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams

Analyze issues with attention to detail

Ability to assess alternative approaches

Proven ability to develop global regulatory strategy recommendations based on precedents and other regulatory intelligence as well as regulations and guidelines

Able to deal with issues of critical importance with minimal oversight

Exercises good judgment in elevating and communicating actual or potential issues to line management

Understands who is responsible for different decisions and escalates as necessary

Applies directions taken by the company

Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork

Intentionally promotes an inclusive culture

Applies given prioritization framework with limited support

Excellent written and oral communication skills required

Excellent skills in leadership, collaboration, negotiation, problem solving, and fostering interpersonal connections through teamwork