(US-California-Los Angeles) Based in the Regulatory Department, the Regulatory Affairs Manager is responsible for developing and executing regulatory strategies to facilitate global CMC submissions. •Write, edit, and compile CMC sections of global license applications and post-approval regulatory filings. •Maintain and amend CMC sections of global regulatory filings. •Serve as the Quality signature for the approval of analytical method and specification change control. •Advise teams and corporate personnel regarding possible areas of regulatory concern and new governmental/regulatory developments. Evaluate GMP related compliance issues and participate in the development of action plans to correct deficiencies. •Act as lead Corporate Regulatory Compliance representative for CMC submission projects associated with foreign and domestic corporate partners. Supervise Corporate Regulatory Compliance Specialists. Establish departmental policies, procedures, and guidelines as well as generating periodic budget forecasts for senior management. Experience with FDA. •Participate and lead regulatory compliance meetings. Required Experience •Minimum 5 years of experience in regulatory affairs and CMC within pharmaceutical development and biologics. •Experience in technical assessment of regulatory compliance and requirements. •Biologics/protein experience required. Management skills at line management levels. •Requires communication skills (both written and oral), excellent negotiation skills and advanced knowledge of regulations and practices pertaining to the manufacture and testing of biological pharmaceutical products. Ability to work in a team or matrix environment. •Ability to collaborate and coordinate with internal and external department groups. Excellent technical writing skills. •Experience in a regulatory compliance position (or equivalent) of in the manufacture and testing (QA, QC, or clinical) of pharmaceutical products and must. •BA or BS in Life Science required. Advance degree preferred.
(US) REGIONAL CLINICAL RESEARCH ASSOCIATES, NATIONWIDE, (with some exceptions) for our client a full-service clinical development organization. This is an excellent opportunity for CRAs looking for a stable and profitable firm in which they can reduce their overall travel and participate in a wide variety of therapeutic areas. As a member of a team that designs, manages and conducts clinical trials, the candidate’s duties will include investigator recruitment, study initiation, routine monitoring, study close-out, site management and more. Quality, consistency, and training is highly emphasized. You will have the opportunity to hone your skills in classroom sessions, one-on-one mentoring relationships, computerized training, and through specialized training in individual therapeutic areas. POSITION REQUIREMENTS Ideal candidates will possess a BA, BS, BSN, or RN degree. S/he will have 2 years experience as a CRA. Strong verbal and written communication skills are required to be successful in this role. This role also requires 60-80% overnight travel initially; however, travel will be closer to a consistent 60% after site initiation. COMPENSATION Compensation is competitive with a base salary range between $50-$72K depending on experience. The package includes a comprehensive benefit package as well as an environment that assures employee opportunity and rewards initiative and teamwork.
(US) IN-HOUSE CLINICAL RESEARCH ASSOCIATE, (PA, FL, TX) for our client, a full-service clinical development organization. This is an excellent opportunity for CRAs looking for a stable and profitable firm in which they can reduce their overall travel and participate in a wide variety of therapeutic areas. As a member of a team that designs, manages and conducts clinical trials, the candidate’s duties will include investigator recruitment, study initiation, routine monitoring, study close-out, site management and more. Quality, consistency, and training is highly emphasized. You will have the opportunity to hone your skills in classroom sessions, one-on-one mentoring relationships, computerized training, and through specialized training in individual therapeutic areas. POSITION REQUIREMENTS Ideal candidates will possess a BA, BS, BSN, or RN degree. S/he will have 2 years experience as a CRA. Strong verbal and written communication skills are required to be successful in this role. This role also requires 50-60% travel. Overnight travel is occasional. COMPENSATION Compensation is competitive with a base salary range between $50-$72K depending on experience. The package includes a comprehensive benefit package as well as an environment that assures employee opportunity and rewards initiative and teamwork.
