- Lead planning, execution, and management of regulatory submissions for assigned vaccines in various phases of clinical development, global marketing applications, and post-approval life cycle activities, as needed
- 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
- Stay abreast of current and evolving regulatory CMC requirements, apply this knowledge to assigned projects, and share knowledge and experience with others to support their development
- 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 equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location:Boston, MAU.S. Base Salary Range:$169, $266,200.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term and/or long-termincentives. employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. EEO StatementTakeda 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 Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time
-
Director, Regulatory Affairs Vaccines Cmc
1 week ago
ARIAD Boston, United States**Pay Range**: · $169, $266,200.00 · **Job ID** R0120763**Date posted** 04/16/2024**Location** Boston, Massachusetts**Pay Range** $169, $266,200.00**About the role**: · At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transfor ...
-
Director, Regulatory Affairs Vaccines CMC
2 weeks ago
Workday Boston, MA, United StatesBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I sub ...
-
Director, Regulatory Affairs Vaccines CMC
1 week ago
Takeda Boston, United StatesAbout 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 possi ...
-
Director, Regulatory Affairs Vaccines CMC
2 weeks ago
Takeda Boston, MA, United StatesDirector, Regulatory Affairs Vaccines CMC · Vaccines prevent 2 to 3 million deaths each year and have transformed global public health. For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda's global vaccine business is applyi ...
-
Contract - Quality Assurance Specialist, Cmc
5 days ago
Vedanta Biosciences Cambridge, United States**Title: Contract - Quality Assurance Specialist, CMC** · **Location: Cambridge, MA and Acton, MA** · **Reports to: Supervisor, Quality Assurance** · **About Vedanta Biosciences**: · **The Role**: · The QA CMC Specialist is responsible for performing a wide variety of activities ...
-
CMC Project Manager
4 days ago
HireMinds Boston, United StatesOur Vaccine Client in Boston, MA is growing and looking to add a CMC Project Manager to their Technical Operations team (Hybrid onsite & WFH) This role will work cross functionally across Tech Ops, including Manufacturing, Supply Chain, and Assay Development. Will be a member of ...
-
Regulatory Affairs Cmc Officer
5 days ago
Cytiva Marlborough, United States**Be part of something altogether life-changing** · Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative ...
-
Director, Microbial Process Development
1 week ago
HireMinds Boston, United StatesDirector, Bioprocess Development · Boston, MA · Our vaccine client in Boston, MA is looking to add a hands-on, Director, Bioprocess Development (Microbial/Fermentation) to their team This role will work on-site, in the lab to lead the development of scalable processes for CMC dev ...
-
VP, Asset Management
1 week ago
Replimune Group Boston, MA, United StatesOverview · The Vice President of CMC is responsible for the leadership and management of Replimune's Manufacturing function at the Framingham site and the supporting global Process Development function. The role holder will oversee all aspects of drug substance and drug product d ...
-
Senior Director, Regulatory Affairs CMC
1 week ago
Alexion Pharmaceuticals Boston, MA, United StatesThis is what you will do:The Senior Director of Regulatory Affairs Chemistry, Manufacturing, and Controls (RA-CMC) will provide strategic as well as operational leadership of global CMC activities related to Cell & Gene Therapy (GCT) leading to successful registration and life-cy ...
-
Manager, Quality Validation
1 week ago
Cellares Bridgewater, United StatesWe are seeking an innovative and highly motivated Manager, Quality Validation, who will contribute significantly to the growth of the Cellares team. · The Quality Validation team at IDMO Bridgewater facility is responsible for providing Quality Assurance oversight of environmenta ...
-
Director (Device Project Management)
1 week ago
AstraZeneca Boston, MA, United StatesDirector (Device Project Management)Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the place for youAt AstraZeneca, we put patients firs ...
-
EPM Scientific Boston, United StatesJob Description · Job DescriptionSUMMARY · This clinical-stage biopharmaceutical company is looking for an innovative scientist with a strong background in Upstream Process Development to oversee the development of all upstream technical activities for their lead vaccine program. ...
-
Consultant Regulatoty CMC
6 days ago
Proclinical Boston, United States PermanentConsultant Regulatory CMC - Permanent - Boston, MAProclinical is seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant with a strong background in CMC post-approval. This permanent position is located in Boston, MA. · Primary Responsibilities:The succes ...
-
Director/Sr. Director
1 week ago
EPM Scientific Boston, United StatesJob Description · Job DescriptionDirector/Sr. Director - Process Development · Greater Boston Area · Competitive Compensation + excellent bonus/benefits · Duties and Responsibilities: · Lead all process development activities (cell culture/banking/development, fermentation, prot ...
-
Senior Director, AAV Upstream Development
2 weeks ago
AstraZeneca GmbH Boston, MA, United StatesThe Senior Director's is responsible for leading and directing the cell culture activities for Alexion's AAV production platform. The Senior Director will work collaboratively with key functional experts in our Research, Product Development, and Analytics teams, among others to a ...
-
Senior Director, AAV Downstream Development
3 weeks ago
AstraZeneca GmbH Boston, MA, United StatesThis is what you will do: · The Senior Director's is responsible for leading and directing the viral vector purification activities for Alexion's AAV production platform. The Senior Director will collaborate with key functional experts in our Research, Product Development, and A ...
-
Knewin Boston, MA, United StatesDo you have leadership skills and an in depth knowledge within Regulatory Affairs? Do you want to work on innovative projects of importance for our early Respiratory and Immunology portfolio? · At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas ...
-
Associate Director, Regulatory Affairs CMC
1 week ago
Voyager Therapeutics, Inc. Cambridge, United StatesThe Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for new and late stage programs to secure approval of the manufacturing process and control testing for initial clinical trials under ...
-
Global Regulatory Strategy Leader
1 week ago
Bill and Melinda Gates Foundation Cambridge, United States"We are focused on results. Those that can be measured. And those measured in ways beyond numbers. We see individuals, not issues. We are inspired by passion, and compassion for the wellbeing of people. Our methods are based on logic, driven by rigor, results, issues, and outcome ...
Director, Regulatory Affairs Vaccines CMC - Boston, United States - Takeda
Description
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
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.
You will also demonstrate leadership and comprehensive understanding of global vaccines CMC regulations and guidelines by applying interpersonal skills and expert Regulatory Affairs Vaccines (RAV) CMC knowledge to identify, communicate, address, and overcome challenges that arise during development and commercialization. You will successfully communicate and negotiate with international Health Authorities as necessary, directly and indirectly. As part of the RAV CMC team, you will report to the Head, RAV CMC and work with strategic partners globally.
How you will contribute:
