BioSpace
Associate Director, Global Regulatory Affairs, CMC Small Molecules
BioSpace, Boston, Massachusetts, us, 02298
Associate Director, Global Regulatory Affairs, CMC Small Molecules
Join to apply for the
Associate Director, Global Regulatory Affairs, CMC Small Molecules
role at BioSpace. Position overview: Takeda is seeking an Associate Director, GRA CMC Small Molecules to oversee the development and execution of regulatory CMC development and registration strategies. You will be a RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and the commercial lifecycle for assigned products, and you will provide leadership and expertise in global RA CMC regulations and guidelines to address development and commercialization challenges. Responsibilities Plan, execute and manage regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval lifecycle activities. Be a member of global cross-functional teams requiring interpretation of EMA/FDA/ICH/WHO/global regulations to ensure CMC compliance. Support submission teams to define CMC content (data and documentation) for regulatory submissions and review content for conformance with requirements. Contribute to business process development and enhancement. Evaluate new business development opportunities or participate on due diligence teams. Develop and maintain constructive relations with internal and external stakeholders, including cross-functional Takeda colleagues, alliance partners, and Health Authority representatives. Keep project teams, line management, and stakeholders apprised of developments that may impact regulatory success; exercise sound judgement and timely communication. Elevate and communicate actual or potential issues to line management as appropriate. Communicate and negotiate with international Health Authorities as necessary, directly and indirectly. Represent Takeda RA CMC in Health Authority meetings and lead or support CMC preparation activities for meetings on CMC matters. Liaise with Regulatory Agencies, with international experience preferred. Mentor and develop staff as needed, including professional development and project oversight. Evaluate change proposals for regulatory impact and filing requirements. Minimum Requirements/Qualifications BS/BA in a Scientific Discipline; Advanced Degree preferred. 8+ years pharmaceutical Regulatory CMC experience including late-stage development and marketing application experience preferred. Significant Small Molecule experience. Proven ability to liaise with Regulatory Agencies with international experience preferred. Understanding of scientific principles and regulatory CMC requirements for global drug development and post-market support. Ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams. Ability to address issues of critical importance and provide regulatory advice where guidance may be unclear. Demonstrates leadership, problem-solving, flexibility and teamwork. Willingness to travel up to 10-30% for meetings (overnight stays may be required). About Takeda Takeda is transforming patient care through novel specialty pharmaceuticals and patient support programs. We are a patient-focused company that values growth and innovation, with a commitment to deliver Better Health and a Brighter Future to people worldwide. Location: Boston, MA U.S. Base Salary Range: $153,600.00 - $241,340.00 U.S. benefits may include short-term/long-term incentives, medical, dental, vision, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid leave, and other well-being benefits. Salaries and benefits are subject to applicable laws and may vary by location and experience. EEO Statement: Takeda is committed to a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or protected veteran status, in accordance with applicable laws. Locations: Boston, MA Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time
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Join to apply for the
Associate Director, Global Regulatory Affairs, CMC Small Molecules
role at BioSpace. Position overview: Takeda is seeking an Associate Director, GRA CMC Small Molecules to oversee the development and execution of regulatory CMC development and registration strategies. You will be a RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and the commercial lifecycle for assigned products, and you will provide leadership and expertise in global RA CMC regulations and guidelines to address development and commercialization challenges. Responsibilities Plan, execute and manage regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval lifecycle activities. Be a member of global cross-functional teams requiring interpretation of EMA/FDA/ICH/WHO/global regulations to ensure CMC compliance. Support submission teams to define CMC content (data and documentation) for regulatory submissions and review content for conformance with requirements. Contribute to business process development and enhancement. Evaluate new business development opportunities or participate on due diligence teams. Develop and maintain constructive relations with internal and external stakeholders, including cross-functional Takeda colleagues, alliance partners, and Health Authority representatives. Keep project teams, line management, and stakeholders apprised of developments that may impact regulatory success; exercise sound judgement and timely communication. Elevate and communicate actual or potential issues to line management as appropriate. Communicate and negotiate with international Health Authorities as necessary, directly and indirectly. Represent Takeda RA CMC in Health Authority meetings and lead or support CMC preparation activities for meetings on CMC matters. Liaise with Regulatory Agencies, with international experience preferred. Mentor and develop staff as needed, including professional development and project oversight. Evaluate change proposals for regulatory impact and filing requirements. Minimum Requirements/Qualifications BS/BA in a Scientific Discipline; Advanced Degree preferred. 8+ years pharmaceutical Regulatory CMC experience including late-stage development and marketing application experience preferred. Significant Small Molecule experience. Proven ability to liaise with Regulatory Agencies with international experience preferred. Understanding of scientific principles and regulatory CMC requirements for global drug development and post-market support. Ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams. Ability to address issues of critical importance and provide regulatory advice where guidance may be unclear. Demonstrates leadership, problem-solving, flexibility and teamwork. Willingness to travel up to 10-30% for meetings (overnight stays may be required). About Takeda Takeda is transforming patient care through novel specialty pharmaceuticals and patient support programs. We are a patient-focused company that values growth and innovation, with a commitment to deliver Better Health and a Brighter Future to people worldwide. Location: Boston, MA U.S. Base Salary Range: $153,600.00 - $241,340.00 U.S. benefits may include short-term/long-term incentives, medical, dental, vision, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid leave, and other well-being benefits. Salaries and benefits are subject to applicable laws and may vary by location and experience. EEO Statement: Takeda is committed to a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or protected veteran status, in accordance with applicable laws. Locations: Boston, MA Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time
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