Senior Manager, Global Regulatory Affairs CMC - Opportunity to lead global CMC r
Takeda Pharmaceutical, Boston, Suffolk County, MA, United States
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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.
This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows:
This role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows:
With some supervision, leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
RA CMC member on the Global Regulatory CMC team may act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
Has a strong foundational understanding of global RA CMC regulations and guidelines and can apply this understanding to projects to enhance probability of regulatory success and regulatory compliance.
Ability to draw from precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions.
With some supervision, plans, executes and manages regulatory submissions according to the regulatory strategy laid out by the GRA CMC Product/Device lead(s)
Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. With supervision, supports CMC preparation activities for meetings with Health Authorities on CMC related matters.
Interacts directly with international Health Authorities on administrative procedural topics, as required.
Evaluates change proposals for global regulatory impact with some supervision.
As a RA CMC member, ensures and/or enhances regulatory compliance .
Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
~6+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA . Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered.
~ Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
~ Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
~ Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines.
~ Able to deal with issues of critical importance with some supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management.
~ Exercises good judgement in elevating and communicating actual or potential issues to line management.
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. 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" following Takeda's Hybrid and Remote Work policy.
#The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
S. based employees may be eligible for short-term and/ or long-term incentives. 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. 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.
Full time
An employer who violates this law shall be subject to criminal penalties and civil liability.
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.
This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows:
This role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows:
With some supervision, leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.
RA CMC member on the Global Regulatory CMC team may act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
Has a strong foundational understanding of global RA CMC regulations and guidelines and can apply this understanding to projects to enhance probability of regulatory success and regulatory compliance.
Ability to draw from precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions.
With some supervision, plans, executes and manages regulatory submissions according to the regulatory strategy laid out by the GRA CMC Product/Device lead(s)
Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. With supervision, supports CMC preparation activities for meetings with Health Authorities on CMC related matters.
Interacts directly with international Health Authorities on administrative procedural topics, as required.
Evaluates change proposals for global regulatory impact with some supervision.
As a RA CMC member, ensures and/or enhances regulatory compliance .
Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
~6+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA . Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered.
~ Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
~ Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
~ Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines.
~ Able to deal with issues of critical importance with some supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management.
~ Exercises good judgement in elevating and communicating actual or potential issues to line management.
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. 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" following Takeda's Hybrid and Remote Work policy.
#The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
S. based employees may be eligible for short-term and/ or long-term incentives. 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. 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.
Full time
An employer who violates this law shall be subject to criminal penalties and civil liability.