Associate Regulatory Affairs CMC

Overview
The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the regulatory Chemistry Manufacturing and Controls (CMC) department across regions and phases of development. Support may include organizing managing and executing on regulatory CMC projects in support of regulatory submissions. Tasks may include formatting of documents per style guide searching for and organizing data from regulatory repository systems drafting meeting agendas and minutes managing document reviews and other tasks as requested.

What we are looking for:
Strong organizational skills with attention to detail;
Proficient time management skills and ability prioritize workload;
Ability to work both independently and as a member of a team;
Proficient skills in Microsoft Office suite especially Word Excel PowerPoint and Project;
Qualified to work in the U.S. without employer sponsorship;
Experience
o Masters degree and 2 years of Regulatory (CMC preferred) Compliance Quality Biopharmaceutical Pharmaceutical and/or related scientific experience
o OR
o Bachelors degree and 4 years of Regulatory (CMC preferred) Compliance Quality Biopharmaceutical Pharmaceutical and/or related scientific experience
o OR
o Associate degree and 6 years of Regulatory (CMC preferred) Compliance Quality Biopharmaceutical Pharmaceutical and/or related scientific experience
o OR
o High school diploma / GED and 8 years of Regulatory (CMC preferred) Compliance Quality Biopharmaceutical Pharmaceutical and/or related scientific experience

Preferred Qualifications
Degree in life sciences biochemistry or chemistry
Experience in biopharmaceutical or pharmaceutical industry
Familiarity with eCTD structure
Motivated with initiative to learn quickly
Experience in CMC including preparation of submissions to Agencies
Proficient skills in Microsoft Office suite especially Word Excel PowerPoint and Project

Top 3 MustHave Skill Sets
Cando Attitude Ideal candidate does not easily give up. The candidate will be provided direction and support but will need to be methodical and analytical when completing tasks while exhibiting a positive attitude (Amgen is a very large organization and there will be many parties the candidate will need to engage with for project success).
Being Comfortable With Being Uncomfortable Ideal candidate will not only be able to identify problems but also identifies possible solutions. Project end goals will be known but all the inbetween steps may not be known from the start so the candidate will need to navigate and structure the steps without being easily flustered.
Attention to Detail Ideal candidate will be thorough and deliver polished work product.

Daily Responsibilities
Daily responsibilities will be focused on providing submission execution support to products across modalities regions and phases of development
Employee Value Proposition
You will work directly with project teams in support of submission execution. The projects you will be involved with will have a positive impact on key Amgen processes that support the making of human therapeutics and the patients that use them.