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Job Description

About the role:

Under the direction of the Head of CMC Submissions, you will be responsible for providing Submission Ready Standard Application during the preparation of high quality regulatory submissions and a wide range of supporting documentation across the drug development lifecycle including pipeline programs (IMPD/CTA/IND), Marketing Applications (NDA, MAA, BLA, JNDA) and Agency request for information, Briefing Books, Post- Approval changes or compliance updates across all global franchises. You will report to Head of CMC Submissions.

How you will contribute:

• Also the SRS Specialist will also be expected to drive, support and contribute to broader improvement initiatives that contribute to Takeda's overall success.
• Undertake document formatting to ensure consistency with company and health authority submission ready standards.
• Review documents for submission-readiness and conformity company and health authority guidelines.
• Undertake the submission build activities for both paper and electronic regulatory submissions, ensuring submissions are built with submission-ready documents, creating intra-document links, performing quality check and validating compiled submissions, and finalizing submission by required dispatch date.
• Load documents into EDMS and concatenation as required
• Provide training of authors/reviewers through guidance and expertise of system and tools for efficient authoring and review process
• Create, review, and/or maintain CMC submission templates
• Maintain team compliance with company trainings and internal processes and standards
• Collates source documents pertaining to regulatory filings/submissions on request
• On occasion will QC selected CMC sections of regulatory filings
• Project team participation as necessary, information gathering, progress reports and presentations etc.
• Proactively seeks input, feedback and assessment from key stakeholders to drive business improvements
• Assists in the development and implementations of departmental processes, procedures and policies.
• Active promoter of talent, knowledge sharing and collaborative spirit

What you bring to Takeda:

• Minimum 3 years' experience in the Pharmaceutical Industry, or relevant Regulatory environment.
• Degree in Pharmaceutics, Chemistry Chemical Engineering, or closely related field would be ideal.
• Familiarity with pharmaceutical product/process development, regulatory guidelines and experience in regulatory submissions (in particular CMC Module 3 information and QOS documents) throughout out the development lifecycle would be ideal.
• Experience with, ISI Writer, MS Word®, Adobe Acrobat®, EDMS (documentum), and other publishing tools is required
• Working knowledge of current regulations
• Familiarity with CTD format and content of regulatory filings and strong IT skills.
• Demonstrates strong skills in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Working knowledge of current regulations
• Familiarity with CTD format and content of regulatory filings
• Ability to effectively negotiate multiple work streams, IT applications, projects and teams simultaneously

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

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:

$86,500.00 - $135,960.00

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, MALexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.