24 days old

JAPAC Regional Regulatory Lead (RRL) -Senior Manager

Amgen
Thousand Oaks, CA 91360
  • Job Code
    116807862
Amgen

Job ID: R-90521
Location: Thousand Oaks, CA, US 91360
Additional Location: China - Hong Kong

Amgen is seeking a JAPAC Regional Regulatory Lead (RRL) - Senior Manager to join our Regional Regulatory Affairs group, and will work from either our Thousand Oaks, CA or Hong Kong locations. Other Amgen locations could be considered for candidates that have current and/or prior Amgen experience.

Regional Regulatory Leads (RRLs) within the JAPAC RRL group supports one or more products from a JAPAC regional regulatory perspective. As a member of the Global Regulatory Teams (GRTs) for assigned products and a regulatory representative for the JAPAC region, the RRL leads efforts to develop and execute regional regulatory strategies as well as facilitates effective agency interactions by bridging local and global teams. These efforts, which are focused on Japan and China and include support for other JAPAC markets, as appropriate, enable the team to acquire and maintain the required investigational and marketing licenses in collaboration with local, regional, and global stakeholders.

This RRL Senior Manager will interact primarily with Global Regulatory Leaders (GRLs), other GRT members, Local Regulatory Representatives (LRRs), and regional stakeholders (eg, Medical, Commercial, Supply Chain).

This role will report to a JAPAC Regional Regulatory Group Leader based in Thousand Oaks, CA, USA.

This role is accountable for:
  • Developing and executing regional regulatory strategies for assigned products
  • Facilitating local implementation of regulatory activities, in line with approved regional regulatory strategies
  • Representing the JAPAC region on GRTs


This role is responsible for:
  • Advising GRLs/GRTs and other global teams on JAPAC regional considerations in developing and executing regulatory strategies, including the following: (a) focus on Japan and China; (b) innovative regulatory approaches to accelerated approvals; (c) integration of companion diagnostic and device registration strategies
  • Keeping LRRs updated on global regulatory strategies and status, as they impact local regulatory activities in the JAPAC region
  • Ensuring that the JAPAC regional needs are well defined and implemented in collaboration with relevant regional stakeholders (eg, Medical, Commercial, Supply Chain)


Key Activities
  • Lead the development and maintenance of regional regulatory plans (RRPs) for assigned products, which describe regional regulatory strategies including key market considerations, regulatory risk assessment, and contingency planning
  • Communicate global regulatory strategies and status to LRRs and regional stakeholders, as they impact regulatory activities in the JAPAC region
  • Provide regulatory leadership on regional regulatory mechanisms to optimize product development and registration (e.g. when and how to participate in global clinical trials, orphan drug designation, accelerated approvals) in collaboration with LRRs
  • Provide strategic input on regional considerations by sharing regulatory information and implications with the GRT members on an ongoing basis
  • Articulate the likelihood of regulatory success based on proposed strategies
  • Facilitate interactions between LRRs and global stakeholders in executing clinical trial applications/notifications (CTAs/CTNs) and marketing authorization applications (MAAs), including associated response to questions (RTQs) as well as label development and negotiations
  • Consistently communicate well-defined regulatory strategies throughout the organization, such that expectations are clearly understood
  • Partner with LRRs to communicate outcomes of regulatory agency interactions to GRT, local/regional stakeholders, including relevant senior management members
  • Partner with LRRs to communicate current and evolving regulatory landscape (eg, new and developing legislations, regulatory policy, and technical regulatory guidance) in the JAPAC region to global and regional stakeholders
  • Inform Regional Regulatory Group Leader(s) and Regional Regulatory Head of key regulatory issues and lead in proposing solutions in partnership with LRRs


Skills and Knowledge
  • Understanding of drug development
  • Comprehensive understanding of regulatory activities, touch points, and how they affect projects and processes
  • Ability to anticipate regulatory agency responses to strategy
  • Ability to understand and communicate scientific and clinical information
  • Good communication skills - both oral and written
  • Ability to lead and facilitate cross-functional and cross-regional project team interactions
  • Negotiation skills
  • Ability to anticipate and prevent potential issues in a rapidly evolving regulatory landscape and Amgen portfolio
  • Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
  • Cultural awareness and sensitivity to achieve results across global, regional, and local teams
  • Initiative to propose and contribute to process improvements
  • Working in compliance with corporate policies and operating procedures


Basic Qualifications

Doctorate degree and 2 years of experience in regulatory filing and interactions with some regulatory agencies
OR
Master's degree and 4 years of experience in regulatory filing and interactions with some regulatory agencies
OR
Bachelor's degree and 6 years of experience in regulatory filing and interactions with some regulatory agencies
OR
Associate's degree and 10 years of experience in regulatory filing and interactions with some regulatory agencies
OR
High school diploma / GED and 12 years of experience in regulatory filing and interactions with some regulatory agencies

Preferred Qualifications
  • Direct and recent experience in making significant contributions to regulatory filing and interactions with regulatory agencies in the JAPAC region
  • Working knowledge in the registration procedures in the JAPAC region regarding clinical trials, marketing authorization, post-approval changes, line extensions, and license renewals


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

PI116807862

<b>Amgen</b><br/><br/><b>Job ID: </b>R-90521<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><b>Additional Location: </b>China - Hong Kong<br/><br/>Amgen is seeking a JAPAC Regional Regulatory Lead (RRL) - Senior Manager to join our Regional Regulatory Affairs group, and will work from either our Thousand Oaks, CA or Hong Kong locations. Other Amgen locations could be considered for candidates that have current and/or prior Amgen experience.<br><br>Regional Regulatory Leads (RRLs) within the JAPAC RRL group supports one or more products from a JAPAC regional regulatory perspective. As a member of the Global Regulatory Teams (GRTs) for assigned products and a regulatory representative for the JAPAC region, the RRL leads efforts to develop and execute regional regulatory strategies as well as facilitates effective agency interactions by bridging local and global teams. These efforts, which are focused on Japan and China and include support for other JAPAC markets, as appropriate, enable the team to acquire and maintain the required investigational and marketing licenses in collaboration with local, regional, and global stakeholders.<br><br>This RRL Senior Manager will interact primarily with Global Regulatory Leaders (GRLs), other GRT members, Local Regulatory Representatives (LRRs), and regional stakeholders (eg, Medical, Commercial, Supply Chain).<br><br>This role will report to a JAPAC Regional Regulatory Group Leader based in Thousand Oaks, CA, USA.<br><br>This role is accountable for:<br><ul><li>Developing and executing regional regulatory strategies for assigned products</li><li>Facilitating local implementation of regulatory activities, in line with approved regional regulatory strategies</li><li>Representing the JAPAC region on GRTs</li></ul><br><br>This role is responsible for:<br><ul><li>Advising GRLs/GRTs and other global teams on JAPAC regional considerations in developing and executing regulatory strategies, including the following: (a) focus on Japan and China; (b) innovative regulatory approaches to accelerated approvals; (c) integration of companion diagnostic and device registration strategies</li><li>Keeping LRRs updated on global regulatory strategies and status, as they impact local regulatory activities in the JAPAC region</li><li>Ensuring that the JAPAC regional needs are well defined and implemented in collaboration with relevant regional stakeholders (eg, Medical, Commercial, Supply Chain)</li></ul><br><br><b>Key Activities</b><br><ul><li>Lead the development and maintenance of regional regulatory plans (RRPs) for assigned products, which describe regional regulatory strategies including key market considerations, regulatory risk assessment, and contingency planning</li><li>Communicate global regulatory strategies and status to LRRs and regional stakeholders, as they impact regulatory activities in the JAPAC region</li><li>Provide regulatory leadership on regional regulatory mechanisms to optimize product development and registration (e.g. when and how to participate in global clinical trials, orphan drug designation, accelerated approvals) in collaboration with LRRs</li><li>Provide strategic input on regional considerations by sharing regulatory information and implications with the GRT members on an ongoing basis</li><li>Articulate the likelihood of regulatory success based on proposed strategies</li><li>Facilitate interactions between LRRs and global stakeholders in executing clinical trial applications/notifications (CTAs/CTNs) and marketing authorization applications (MAAs), including associated response to questions (RTQs) as well as label development and negotiations</li><li>Consistently communicate well-defined regulatory strategies throughout the organization, such that expectations are clearly understood</li><li>Partner with LRRs to communicate outcomes of regulatory agency interactions to GRT, local/regional stakeholders, including relevant senior management members</li><li>Partner with LRRs to communicate current and evolving regulatory landscape (eg, new and developing legislations, regulatory policy, and technical regulatory guidance) in the JAPAC region to global and regional stakeholders</li><li>Inform Regional Regulatory Group Leader(s) and Regional Regulatory Head of key regulatory issues and lead in proposing solutions in partnership with LRRs</li></ul><br><br><b>Skills and Knowledge</b><br><ul><li>Understanding of drug development</li><li>Comprehensive understanding of regulatory activities, touch points, and how they affect projects and processes</li><li>Ability to anticipate regulatory agency responses to strategy</li><li>Ability to understand and communicate scientific and clinical information</li><li>Good communication skills - both oral and written</li><li>Ability to lead and facilitate cross-functional and cross-regional project team interactions</li><li>Negotiation skills</li><li>Ability to anticipate and prevent potential issues in a rapidly evolving regulatory landscape and Amgen portfolio</li><li>Ability to resolve conflicts and develop a course of action leading to a beneficial outcome</li><li>Cultural awareness and sensitivity to achieve results across global, regional, and local teams</li><li>Initiative to propose and contribute to process improvements</li><li>Working in compliance with corporate policies and operating procedures</li></ul><br><br><b>Basic Qualifications</b><br><br>Doctorate degree and 2 years of experience in regulatory filing and interactions with some regulatory agencies<br>OR<br>Master's degree and 4 years of experience in regulatory filing and interactions with some regulatory agencies<br>OR<br>Bachelor's degree and 6 years of experience in regulatory filing and interactions with some regulatory agencies<br>OR<br>Associate's degree and 10 years of experience in regulatory filing and interactions with some regulatory agencies<br>OR<br>High school diploma / GED and 12 years of experience in regulatory filing and interactions with some regulatory agencies<br><br><b>Preferred Qualifications</b><br><ul><li>Direct and recent experience in making significant contributions to regulatory filing and interactions with regulatory agencies in the JAPAC region</li><li>Working knowledge in the registration procedures in the JAPAC region regarding clinical trials, marketing authorization, post-approval changes, line extensions, and license renewals</li></ul><br><br>Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.<br><br>Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.<br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/X7K1mDc2YlLrilR4ueYQ8"> <p>PI116807862</p>

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Posted: 2020-01-03 Expires: 2020-02-03

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JAPAC Regional Regulatory Lead (RRL) -Senior Manager

Amgen
Thousand Oaks, CA 91360

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