Full-Time CMC Submission Lead
Job Description
Job Title: CMC Submissions Lead
Location: Cambridge, MA
About the role:
You will manage the Global CMC Regulatory Submissions preparation for Marketing Applications (e.g. NDA, MAA, BLA, JNDA) and Post-Approval Changes. You will work with cross-functional stakeholders in Regulatory, Global Manufacturing Sciences subject matter experts, Quality representatives, and other contributing functions to set up the framework for submissions in the Electronic Document Management System (EDMS) and support the submission preparation team members in its use. This is a hybrid role that reports to the Submissions Team Lead.
How you will contribute:
- Maintain submission preparation timeline and manage submission readiness, finalization, and archiving of submissions.
- Receive Reg-CMC strategy and submission details sufficient to create timeline.
- Collaborate with Reg-CMC and Content owners to prioritize and align deliverables.
- Establish document structure in Electronic Document Management System (EDMS).
- Create binders and applicable templates and maintain up to date during submission preparation
- Support author management, content verification, and final quality check.
- Provide support and lead meetings for kickoff, roundtables, content / data reconciliation, and follow-ups, as well as support RTQ process (e.g., Rapid Response Team).
- QC, formatting, uploading, filing history, headers / footers, linking, and folder/ vdoc structure.
- Document management and legalization.
- Support issue resolution and mitigation planning activities.
- Initiate approval workflows and provide submission ready docs to publishing.
What you bring to Takeda:
- BS/BA Degree in a Scientific Discipline required
- Minimum 4 years experience in pharmaceutical or medical device industry in a relevant field, e.g. Regulatory CMC, Pharmaceutical Development, Analytical Development, Production, Quality Assurance.
- Familiarity with global regulatory guidelines and experience in regulatory submission (CMC Module 3 information and QOS documents)
Important Considerations:
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
- Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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.
#GMSGQ #ZR1 #LI-MA1 #LI-Hybrid
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, MA
U.S. Base Salary Range:
$108,500.00 – $170,500.00
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-term incentives. U.S. based 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. U.S. based 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 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
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
How to Apply
Please place a formal application at : https://takeda.wd3.myworkdayjobs.com/External/job/Boston-MA/CMC-Submissions-Lead_R0119596106 total views, 0 today