Regulatory Submissions CMC Lead

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Job Description

Location: Boston/Cambridge, MA

Hybrid Workplace position

About the role:

The Regulatory Submissions CMC Lead in CMC Submission Management (CSM) manages the Global CMC Regulatory Submissions for Marketing Applications (NDA, MAA, BLA, JNDA) and Post-Approval Changes for GMS Division by working closely with Global Mfg Sciences subject matter experts, Quality representatives, and cross-functional stakeholders in Regulatory. The Lead will also support the CSM Team Lead in Global Manufacturing and Supply (GMS) where R&D deliverables are needed for regulatory submissions.

How you will contribute:

• Maintain doc plan/timeline

  • Receive TOC aligned with Reg-CMC strategy

  • Collaborate with Reg-CMC and Content owners to prioritize and align deliverables

• Establish document structure

  • Create vdoc and applicable templates

• Support author management

  • Provide support to meetings for kickoff, roundtables, content / data reconciliation, and follow-ups

  • Support RTQ process (e.g., Rapid Response Team)

  • Maintain content verification/approval workflow

• Provide support document management

  • QC, formatting, uploading, filing history, headers / footers, linking, and folder / vdocstructure

  • Document legalization, as needed

• Support issue resolution and mitigation planning activities

• Manage submission readiness

  • Support content verification and the final quality check

• Prepare deliverables for support of submissions

  • Transfer TOCs

  • Provide submission-ready docs to publishing

  • Archive necessary documents

DIMENSIONS AND ASPECTS

Leadership

• Strong team member with demonstrated ability to work collaboratively with others as well as being able to take initiative and exercise independent judgment.

• Works with authors to develop and manage all activities associated with preparing, reviewing, and publishing CMC submissions for commercial products.

Decision-making and Autonomy

• Very good prioritization skills to balance key priorities.

• The ability to balance between customer and system requirements.

Interaction

• Strong communication skills, both written and verbal.

• Ability to engage and influence a range of personnel, peers, and superiors with a collaborative style.

Innovation

• Flexibility to support the department in all critical business needs and organizational objectives.

• Drive and energy to multi-task in a fast-paced environment, with flexibility and strength to navigate through crises.

Complexity

• Knowledge of drug development requirements for both biologics, plasma, and chemically synthesized products, as well as devices and combination products for the entire commercial product portfolio (30+ global commercial brands)

• Ability to represent CMC Regulatory Submissions as a member of project teams.

• Ability to assess needs, apply experience and develop solutions to complex issues and determine and/or negotiate the most appropriate course of action in a timely manner.

What you bring to Takeda :

Technical/Functional (Line) Expertise

• BS/BA Degree in a Scientific Discipline (an Advanced Degree is preferred).

• 4+ years of pharmaceutical Regulatory CMC experience in a supportive role, or equivalent industry experience (e.g. Pharmaceutical Development, Analytical Development, Production, Quality Assurance).

• Familiarity with global regulatory guidelines and experience in regulatory submission (CMC Module 3 information and QoS documents) is essential

• Demonstrates attention to detail and problem-solving abilities.

• Exercises appropriate judgment when working with project teams.

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

• Excellent written and oral communication skills are required. 

Skills

• Working knowledge of current regulations.

• Knowledge of European and US regulatory requirements for drug products and medical device submissions.

• IT skills.

• Familiarity with CTD format and content of regulatory filings.

Behaviors

• Proactively seeks input, feedback, and assessment from key stakeholders to drive business improvements

• Embodies Takeda's leadership behaviors, coaches and provides oversight on contractors, and ensures adequate resourcing of CMC submissions

• Focusing on the few priorities, and providing superior results.

• Elevating capabilities for now and the future.

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.

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, or 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.

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time