Think Different. Do Different. Be Different.
Alcami is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving drugs around the world. A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.
The Regulatory Affairs Specialist is accountable for driving results in a fast-paced environment by performing activities to ensure that regulatory submissions support active pharmaceutical ingredient (API) business needs and that the business remains compliant with regulatory filings. Activities include preparation and submission of regulatory filings, written and verbal communication with regulatory agencies and clients, and providing regulatory affairs information and counsel to other site functions. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.
Education and Experience
Alcami Core Leadership Competencies
What We Offer You:
Diversity and Inclusion:
Alcami values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.