Regulatory Affairs Mgr

Career Category

Regulatory

Job Description

Manager - International Regulatory Lead

Role Name: Manager – International Regulatory Lead (IRL)

Department Name: International Regulatory Team, Global Regulatory Affairs

Role GCF: 5A

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ABOUT THE ROLE

Role Description

The International Regulatory Lead (IRL) Manager 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.

Roles & Responsibilities

- 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, contributes 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 manages 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.

- Builds 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.

Basic Qualifications and Experience

· Doctorate degree OR

· Master's degree and 3 years of relevant regional regulatory experience OR

· Bachelor's degree and 5 years of relevant regional regulatory experience OR

· Associate degree and 10 years of relevant regional regulatory experience OR

· High school diploma/GED and 12 years of relevant regional regulatory experience.

Functional Skills

Must-Have Skills

• 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 impact 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.

Good-to-Have Skills

• 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.

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