To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #02608

About our client Our client is the biotech division of a world leading healthcare company that has developed a reputation for successfully bringing complex products to market in a variety of therapeutic areas. With an experienced clinical team and empowering corporate culture that is focused on the professional development of its employees, this is a great opportunity for the right candidate! Position Location Regulatory Affairs Manager Southern California Salary Reports to Highly competitive package, commensurate with experience Management Responsibilities 1) Develop and execute regulatory plans for complex projects, including maintenance of BLAs 2) Represent or lead the RA function on assigned cross-functional project teams 3) Monitor applicable regulatory requirements 4) Ensure compliance with company and external standards 5) Establish appropriate communication within RA and other functions primarily at project level 6) Perform gap analysis and propose solutions 7) Develop and document sound regulatory decisions and justifications 8) Ensure project teams, and business objectives and deliverables are aligned with regulatory strategy 9) Perform direct supervision of individuals 10) Review promotional material or SOPs for compliance with local and global regulations Requirements 1) Bachelor’s degree in related scientific discipline (Ph. D a plus) 2) Minimum 5 years of regulatory experience 3) Experience in biologics preferred 4) 4+ years of experience in pharmaceutical (drug, not device) regulatory affairs 5) Experience as ‘lead’ CRA person on at least one NDA submission 6) Strong experience in change control procedures and management 7) Ability to manage complex projects and timelines in a matrix team environment 8) Ability to lead and coach others 9) Ability to identify compliance risks and escalate when necessary (independently) 10) Good interpersonal skills, including strong negotiation skills 11) Strong communication (oral/written) and presentation skills