Amgen Regulatory Affairs Manager - CMC in Cambridge, United Kingdom

Title: Regulatory Affairs Manager - CMC Europe/Emerging Europe

The company:

Amgen is one of the world's leading independent biotechnology companies, with global revenues in excess of $18 billion and over 18,000 employees. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.

The role:

The Regulatory Professional will play a key role in developing and executing CMC regulatory strategies for new marketing authorisation applications, clinical trial applications and throughout whole product lifecycle for the Europe/Emerging Europe region (EU, CIS, Balkans, Israel).

Responsibilities will include:

Oversee and review the preparation of M2 and 3 CMC components of filings

Accountable for management of regional CMC filings from marketing authorisation to post-approval supplements, renewals and responses to questions across assigned products and countries.

Authoring and coordinating responses to questions across assigned products and countries.

Gathering, consolidating and analysing regulatory intelligence for Intercontinental region and support its application to product-specific activities

Project management of submissions and monitoring status of applications

Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered

Provides guidance for regulatory assessments of change control requests

Provide regional/country, product & regulatory expertise and clarification on regional CMC RA requirements

Skills / Competencies:

In-depth experience of pharmaceutical/biotechnology or medical device industry

Strong record of related experience within Regulatory Affairs

Strong communication skills - oral and written Organizational skills

Strong interpersonal skills

Ability to develop solutions to technical and organizational issues in order to improve performance and productivity

Strong computer skills, including word processing, database document repository and project management software

Strong team player with a commitment to customer service

Attention to detail

Relationship building

Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy and respect

Time and project management skills

Problem solving

Prioritisation

Drive for results

Process management

Ability to work in a fast paced environment

Technical Skills

CMC- specific regulatory knowledge & experience within biotechnology

Direct experience with EU and EM market applications - MAAs or variations

Good understanding and direct experience of ex US filings

Creation and execution of regional regulatory strategies - MAAs or variations

Management of intelligence

Expanding knowledge of related disciplinary areas

Understands the core business process and purpose of the functional area in Amgen's commercialization process

Developing own project management techniques

Enhances own knowledge through understanding business trends and objectives

Current knowledge and application of CMC hot topics and knowledge of EU/EM legislation and guidance for biotechnology products

Basic Qualifications

BS (MS or higher preferred) life sciences, engineering or related field

Amgen is an equal opportunities employer.

HJE 2017