Vacancy expired!
Job Description: SMCI is seeking a Sr. Associate Regulatory Affairs - CMC to provide varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across countries 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, managing document reviews, and other tasks as requested.
This position may be assigned to a client that requires all individuals on-site to have the COVID-19 vaccination. The individual must be fully vaccinated before starting work at such a client site.
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;
Commitment of a 40-hour work week in Thousand Oaks, California
Experience
o Master's degree and 2 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience
o OR
o Bachelor's 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 ProjectRequired Skills: Regulatory Affairs / Quality Assurance, biotech or small molecule. Don't hesitate! Submit your resume today. SMCI is an EEO employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, national origin, disability, age, genetic information, marital status, military, and veteran status. Members of minority groups, Vietnam Era Veterans and individuals with mental or physical disabilities are encouraged to contact us regarding employment opportunities. In addition, in order to support the provision of business to minority-owned and Women-owned businesses (MWBE), such MWBE are encouraged to contact us regarding subcontracting business opportunities with our firm. (No third parties, please)(H1 sponsorship currently unavailable)(Local candidates only, please) Vacancy expired!
