Manager - International Regulatory Lead (IRL)

 
What you will do 
Let’s do this. Let’s change the world. In this vital role you will provide regulatory leadership & expertise for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management.

Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives.

Provides regulatory direction/expertise on the international regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, expedited regulatory designations, regulatory reliance mechanisms, compassionate use and pediatric plans).

Under general supervision, plans regulatory submissions (e.g. clinical trial, marketing authorization applications and lifecycle management) for products within Amgen's portfolio.

Under general supervision, supplies to the development of international regulatory strategy documents (regulatory product filing plan, strategies, risks associated with the potential Agency outcomes and contingency planning, estimate likelihood of success) and communicates to others, as appropriate.

Provides and maintains clinical trial and/or marketing application documentation (excluding Chemistry, Manufacturing & Controls documentation). May author documents/redact such documents to support a regulatory filing.

Directs development of and handles the international label submission strategy, leads the negotiation activities with cross-functional teams and is accountable for the label deviation requests and outcomes.

Supports local regulatory teams in triaging queries from health authorities, and where appropriate, helps identify existing responses to same or similar questions, leveraging knowledge management.

Participates as a member of the Global Regulatory Team (GRT), and various global clinical and labelling focused teams.

Shares regulatory information and implications with the GRT and other global teams on an ongoing basis and provides advice on international considerations.

Partners with peers to agree on product strategy including projected submission and approval time.

Maintains regular communications with the local teams to ensure alignment on strategy and to share product development status.

Establishes effective relationships and communication paths across the global, regional and local elements of the global regulatory affairs function.

Maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to Amgen products.

Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.

  
 
What we expect of you 

Doctorate degree OR

Master’s degree and 4 to 6 years of relevant regional regulatory experience OR

Bachelor’s degree and 6 to 8 years of relevant regional regulatory experience OR

Diploma and 10 to 12 years of relevant regional regulatory experience

?
Basic Qualifications:

Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products

Comprehensive knowledge of regulatory principles and understanding of regulatory activities, and how they have an effect on other projects and/or processes

General awareness of the registration procedures/challenges in International countries for Clinical Trial Applications, Marketing Applications and lifecycle management activities.

Preferred Qualifications:

Ability to resolve conflicts and develop a course of action leading to a beneficial outcome

Cultural awareness and sensitivity to achieve results across country, regional and international borders.

Soft Skills:

Strong communication skills, both oral and written

Ability to understand and communicate scientific/clinical information

Ability to work effectively with global, local and virtual teams

High degree of initiative and self-motivation

Planning and organizing abilities

Ability to manage multiple priorities successfully

Team-oriented, with a focus on achieving team goals

Good negotiation and influencing skills.

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 with 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.