BioSpace
Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity
BioSpace, Washington, District of Columbia, us, 20022
Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity
Join to apply for the
Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity
role at
BioSpace .
How might you defy imagination? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
What You Will Do In this vital role you will support products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules.
To lead GRTs within Amgen’s GRAAS organization
To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications
Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs
Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives
Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the products Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent
Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)
Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)
Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment; advise product teams and GRT on implications of pertinent changes
Assess regulatory mechanisms to optimize product development (eg, expediting FIH studies, Orphan Drug Designation, Fast Track Designation, conditional /accelerated approval, compassionate use, and pediatric plan) and ensure appropriate incorporation into the global regulatory strategy
Clearly and succinctly communicate regulatory strategies, associated risks, mitigations, and contingencies to the organization such that the probability of regulatory success and potential outcomes are well understood
Lead GRTs and product teams in formal and informal communications with regulatory agencies
Lead the approach and strategy for formal interactions with Regulatory agencies, especially those which could impact the global product strategy
Represent Amgen Regulatory on external partnership teams at the product level
Lead regulatory process improvements and initiatives
Basic Qualifications
Doctorate degree and 5 years of regulatory experience in biotech or science
Masters degree and 8 years of regulatory experience in biotech or science
Bachelor’s degree and 10 years of regulatory experience in biotech or science
Preferred Qualifications
Contemporary obesity experience desired
Demonstrated ability to lead regulatory aspects of highly complex programs in late development
Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application
Ability to lead and build effective teams
Strong communication skills—both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and mitigate against future strategic issues and uncertainties
Ability to resolve conflicts and develop a course of action
Cultural awareness and sensitivity to achieve global results
Planning and organizing abilities
Able to prioritize and manage multiple activities
Ability to make complex decisions and solve problems
Ability to deal with ambiguity
Organizational savvy
Negotiation skills
What You Can Expect Of Us
Comprehensive employee benefits package, including a retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan.
Stock‑based long‑term incentives.
Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.
Flexible work models, including remote work arrangements, where possible.
Apply Now for a Career That Defies Imagination Objects in your future are closer than they appear. Join us. amgen.com/careers
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Legal
Industry
Internet News
#J-18808-Ljbffr
Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity
role at
BioSpace .
How might you defy imagination? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
What You Will Do In this vital role you will support products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules.
To lead GRTs within Amgen’s GRAAS organization
To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications
Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs
Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives
Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the products Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent
Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)
Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)
Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment; advise product teams and GRT on implications of pertinent changes
Assess regulatory mechanisms to optimize product development (eg, expediting FIH studies, Orphan Drug Designation, Fast Track Designation, conditional /accelerated approval, compassionate use, and pediatric plan) and ensure appropriate incorporation into the global regulatory strategy
Clearly and succinctly communicate regulatory strategies, associated risks, mitigations, and contingencies to the organization such that the probability of regulatory success and potential outcomes are well understood
Lead GRTs and product teams in formal and informal communications with regulatory agencies
Lead the approach and strategy for formal interactions with Regulatory agencies, especially those which could impact the global product strategy
Represent Amgen Regulatory on external partnership teams at the product level
Lead regulatory process improvements and initiatives
Basic Qualifications
Doctorate degree and 5 years of regulatory experience in biotech or science
Masters degree and 8 years of regulatory experience in biotech or science
Bachelor’s degree and 10 years of regulatory experience in biotech or science
Preferred Qualifications
Contemporary obesity experience desired
Demonstrated ability to lead regulatory aspects of highly complex programs in late development
Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application
Ability to lead and build effective teams
Strong communication skills—both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and mitigate against future strategic issues and uncertainties
Ability to resolve conflicts and develop a course of action
Cultural awareness and sensitivity to achieve global results
Planning and organizing abilities
Able to prioritize and manage multiple activities
Ability to make complex decisions and solve problems
Ability to deal with ambiguity
Organizational savvy
Negotiation skills
What You Can Expect Of Us
Comprehensive employee benefits package, including a retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan.
Stock‑based long‑term incentives.
Award‑winning time‑off plans and bi‑annual company‑wide shutdowns.
Flexible work models, including remote work arrangements, where possible.
Apply Now for a Career That Defies Imagination Objects in your future are closer than they appear. Join us. amgen.com/careers
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Legal
Industry
Internet News
#J-18808-Ljbffr