Takeda
Senior Manager, Global Regulatory Project Management and Strategic Planning
Takeda, Boston, Massachusetts, us, 02298
Overview
All candidates should make sure to read the following job description and information carefully before applying. Senior Manager, Global Regulatory Project Management and Strategic Planning — Takeda. Remote-based within Global Regulatory Affairs.
This range is provided by Takeda. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range: $137,000.00/yr - $215,270.00/yr
About Takeda 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 three 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 position is currently classified as remote in accordance with Takeda's Hybrid and Remote Work policy.
Responsibilities
Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products of medium complexity are established and maintained, and plans & directs the seamless execution of the GRT goals.
Leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for early to late phase programs by providing effective Project Management leadership, oversight, direction and planning.
Directly supports program GRL by ensuring project management and regulatory operational support for the asset is effective, seamless and delivering to expectations. Performs regulatory operational activities and directly oversees vendors providing operational support for assigned programs.
Partnering with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional submission working groups (SWG) meetings, to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy for moderately complex programs and submissions.
Partner with the GRL to ensure Global Product Team (GPT) regulatory goals are cascaded and that the Global Regulatory Strategy Plan is operationalized and executed upon. Ensure seamless alignment of operational plans with Global Project Management (GPM) team and Therapeutic Area Units (TAUs)/Business Units (BUs) asset strategies.
Qualifications
Bachelors degree required. Emphasis in Science preferred. Advanced degree preferred
Ideal candidate has 6 yrs related experience, preferably with 4 yrs in regulatory
Advanced education or credentialing in regulatory affairs and project management preferred. Demonstrated expert experience leading high performance teams and mentoring colleagues.
Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required.
At least one major (original or supplement) and several minor (amendment) filing experiences in one or more jurisdictions, along with eCTD experience is preferred.
Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support.
Proven ability to provide regulatory operational support and guidance.
Able to deal with issues of critical importance, provide regulatory operational advice and make reasoned decisions on regulatory operational issues.
Demonstrates leadership, problem-solving ability, flexibility and teamwork.
Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging.
Excellent interpersonal and negotiation skills.
Demonstrates strong ability to collaboratively lead without line authority, interact and work effectively with other departments as well as external organizations. Demonstrated experience in leading decision-making within a cross-functional, cross-cultural, global team structure in a matrix environment.
Excellent organizational skills, ability to multitask and with attention to detail; capable of managing multiple projects within assigned timelines.
Ability to apply scientific principles to assess issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
Analytical and problem-solving skills with the ability to identify issues and opportunities and provide direction to teams to explore alternatives.
Experience with project management software and tools (e.g. MS Project, OnePager, Office Timeline, SharePoint etc.).
Job Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Project Management and Information Technology
Industries: Pharmaceutical Manufacturing
Equal Opportunity Takeda is an equal opportunity employer. Takeda is committed 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, or protected veteran status, in accordance with applicable laws.
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All candidates should make sure to read the following job description and information carefully before applying. Senior Manager, Global Regulatory Project Management and Strategic Planning — Takeda. Remote-based within Global Regulatory Affairs.
This range is provided by Takeda. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range: $137,000.00/yr - $215,270.00/yr
About Takeda 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 three 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 position is currently classified as remote in accordance with Takeda's Hybrid and Remote Work policy.
Responsibilities
Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products of medium complexity are established and maintained, and plans & directs the seamless execution of the GRT goals.
Leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for early to late phase programs by providing effective Project Management leadership, oversight, direction and planning.
Directly supports program GRL by ensuring project management and regulatory operational support for the asset is effective, seamless and delivering to expectations. Performs regulatory operational activities and directly oversees vendors providing operational support for assigned programs.
Partnering with the program Global Regulatory Lead (GRL), co-lead and facilitate product-specific Global Regulatory Team (GRT) meetings and cross-functional submission working groups (SWG) meetings, to oversee, plan and deliver GRT goals and regulatory submissions in accordance with regulatory strategy for moderately complex programs and submissions.
Partner with the GRL to ensure Global Product Team (GPT) regulatory goals are cascaded and that the Global Regulatory Strategy Plan is operationalized and executed upon. Ensure seamless alignment of operational plans with Global Project Management (GPM) team and Therapeutic Area Units (TAUs)/Business Units (BUs) asset strategies.
Qualifications
Bachelors degree required. Emphasis in Science preferred. Advanced degree preferred
Ideal candidate has 6 yrs related experience, preferably with 4 yrs in regulatory
Advanced education or credentialing in regulatory affairs and project management preferred. Demonstrated expert experience leading high performance teams and mentoring colleagues.
Significant experience in global drug development regulations, regulatory submissions, lifecycle management, compliance, business systems technology and process is required.
At least one major (original or supplement) and several minor (amendment) filing experiences in one or more jurisdictions, along with eCTD experience is preferred.
Understanding of scientific principles and regulatory standards/requirements relevant to global drug development and post-market support.
Proven ability to provide regulatory operational support and guidance.
Able to deal with issues of critical importance, provide regulatory operational advice and make reasoned decisions on regulatory operational issues.
Demonstrates leadership, problem-solving ability, flexibility and teamwork.
Excellent verbal and written communication skills and ability to prepare effective presentations with focused messaging.
Excellent interpersonal and negotiation skills.
Demonstrates strong ability to collaboratively lead without line authority, interact and work effectively with other departments as well as external organizations. Demonstrated experience in leading decision-making within a cross-functional, cross-cultural, global team structure in a matrix environment.
Excellent organizational skills, ability to multitask and with attention to detail; capable of managing multiple projects within assigned timelines.
Ability to apply scientific principles to assess issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
Analytical and problem-solving skills with the ability to identify issues and opportunities and provide direction to teams to explore alternatives.
Experience with project management software and tools (e.g. MS Project, OnePager, Office Timeline, SharePoint etc.).
Job Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Project Management and Information Technology
Industries: Pharmaceutical Manufacturing
Equal Opportunity Takeda is an equal opportunity employer. Takeda is committed 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, or protected veteran status, in accordance with applicable laws.
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