Amgen

Regulatory Affairs Director - Biosimilars

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Apr 06, 2021
Ref
R-114926
Required Education
Other
Position Type
Full time
HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you're part of something bigger, it's because you are. 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. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.

Regulatory Affairs Director - Biosimilars

Live

What you will do

Let's do this. Let's change the world. In this vital, product-facing role in the Biosimilars Business Unit (BBU) Regulatory Affairs organization, you will provide leadership as the Global Regulatory Lead (GRL) on 1 or more molecules (e.g., biosimilars and/or originator assets). The Regulatory Affairs Director - Biosimilars is responsible for development and execution of the global regulatory product strategy; leading global regulatory team(s), and representing Global Regulatory Affairs on the product development team and other key commercialization governance bodies. The purpose of this role is:
  • To lead one or more Global Regulatory Teams supporting the BBU
  • To develop comprehensive regulatory strategies across the portfolio that take 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 expertise and guidance to product teams (eg, Product Team (PT), Evidence Generation Team (EGT), Global Safety Team (GST))


Key Activities will include:

Strategy and Execution
  • Develops Global Regulatory Strategic Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan
  • Represents GRA on PT and EGT to ensure development of product registration strategies and development plans aimed at achieving regulatory approval and product labeling
  • Provides 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
  • Leads development, review and approval of the target product label (TPL)
  • Obtains input from the GRT members (e.g. regional leads, RA CMC, Safety, etc.) to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance
  • Leads the planning and implementing global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes)
  • Ensures consistency of evidence-based global product communication (e.g. regulatory submission documents)
  • Conducts contingency regulatory planning/risk assessment for global product development strategies and agency interactions
  • Monitors and assess impact of relevant global regulations, guidances, and current regulatory environment
  • Ensures guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug Designation, Breakthrough Therapy or PRIME designations, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) are assessed and incorporated into the global regulatory strategy
  • Consistently communicates well defined, successful regulatory strategies throughout the organization such that expectation is understood
  • Produces strategies that provide innovative alternatives which communicate the associated risks
  • Communicates Amgen's position consistently cross-functionally and across all documents
  • Develops the ability to articulate and educate the likelihood of regulatory success based on proposed strategies
  • Develops ability to accurately predict expectations and outcomes by regulatory agencies


Health Authority Interactions
  • Directs global regulatory agency interaction strategies, in collaboration with regional colleagues
  • Ensures effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams)
  • Ensures consistent communication of product information to Health Authorities
  • Attends key regulatory agency meetings which could impact the global product strategy


Collaboration
  • Leads GRT to develop and execute team goals
  • Provides coaching and mentoring to GRT members
  • Integrates regional regulatory representative input into GRT and regulatory plans
  • Communicates and ensures alignment of global functional and cross-functional goals and objectives.
  • Represents Global Regulatory Affairs on key commercialization teams (e.g, PT, EGT, GST)
  • Represents Amgen GRA on external partnership teams at the PT level
  • Provides education and training on regulatory strategies and compliance issues to other PT functions
  • Ensures regulatory product compliance for product (e.g. PMCs, pediatric and other agency commitments)
  • Support vendor oversight and management for outsourced regulatory activities


External

Under the leadership of the GRAAS Policy leaders:
  • Advocates for Amgen/GRAAS by building strong relationships with key external stakeholders including senior regulatory agencies, trade associations, and influential professional bodies
  • Works externally to influence regulatory legislative environment in line with Amgen policy priorities for the therapeutic area
  • May participate in external review process for commenting based on expertise.
  • May participate in external policy activities as indicated by expertise.
  • As assigned by management, develop regulatory due diligence assessment of licensing/acquisition opportunities.


Work

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The regulatory professional we seek is a leader with these qualifications.

Basic Qualifications:
  • Doctorate degree and 4 years of regulatory experience in biotech or science
  • OR Master's degree and 8 years of regulatory experience in biotech or science
  • OR Bachelor's degree and 10 years of regulatory experience in biotech or science


Preferred Knowledge and Skills:
  • Demonstrated ability to lead 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 & uncertainties
  • Ability to resolve conflicts and develop a course of action
  • Cultural awareness and sensitivity to achieve global results


Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.
  • Vast opportunities to learn and move up and across our global organization
  • Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
  • Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits


Apply now for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com

Equal Opportunity Statement

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 a 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 an accommodation.

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.