Director, Regulatory Affairs Vaccines Cmc

2 weeks ago

Boston, United States Takeda Pharmaceutical Full time

**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 a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development. You will represent the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams (commercial, clinical development, delivery, quality, etc.) to ensure that data are identified, obtained and effectively presented for the registration of products world-wide. The role requires strong focus on analytical, manufacturing, and facilities compliance.

**How you will contribute**:

- Participate in technical development teams which require experienced interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization
- Lead regulatory compliance assessment with respect to filing requirements for assigned vaccines throughout development and the commercial life cycle
- Define CMC content (data and documentation) requirements for regulatory submissions and compile/review this content for conformance with established requirements
- Represent Takeda RAV CMC in Health Authority meetings and lead or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
- Interact directly with international Health Authorities, as required. Participate in and/or lead agency meetings on CMC topics.
- Ensure project team colleagues, line management, and key stakeholders are apprised of risks that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
- May serve as direct/matrix manager of RAV CMC staff, depending on project. Responsible for prioritization of workload and professional development of staff where applicable.

**Minimum Requirements/Qualifications**:

- BS/BA Degree in a scientific/engineering discipline required, Advanced Degree preferred.
- At least 10 years Regulatory CMC experience (vaccines or biologics experience required). Alternatively 5 years Regulatory CMC experience combined with 5 years relevant vaccines or biologics experience (e.g. Pharmaceutical Development, Process Development, Analytical Development, Production, Quality Assurance). Experience with managing BLA/MAA content and format required.
- Experience with regulatory registration of biological drug substances or drug products (including sterile parenteral dosage forms) is required.
- Excellent written and oral communication skills required.
- Demonstrated track record of successful interactions with US FDA, European Agencies and, preferably, other global health authorities related to CMC submissions.
- Understanding of scientific principles and regulatory CMC requirements relevant to global vaccine development, registration, and post-market support. Proven ability to provide strategic regulatory guidance to teams.
- Demonstrated ability to deal with issues of critical importance, provide regulatory advice and experience with developing reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Demonstrated leadership, problem-solving ability, flexibility and teamwork
- Exercises good judgement in elevating and communicating actual or potential regulatory risks to teams and line management.
- Active participation in Agency/Industry groups/forums preferred.
- Some international travel may be required.

**What Takeda can offer you**:

- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- 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

**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.

RM-LI

**Takeda Compensation and Benefits Summary**

We understand compensation is an important factor as you consider the next step in your career. We are committed to equit

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