Biotech > Jobs

US-CA-Redwood: Director, Regulatory Affairs

Date: 19-Jun-2013
To see other BioTech job opportunities, please visit

Director, Regulatory Affairs

* Performs regulatory strategic analysis (planning, development & delivery) * Displays a strong ability to lead and direct interdisciplinary teams for regulatory activities * Strongly connected and versed in regulatory systems use such as * Publishing systems, Word, Visio, Excel * Strong attention to detail along with problem solving, organizational and decision-making skills. * Exceptional regulatory communication skills including extensive experience with representing regulatory strategy to competent authorities, development teams and senior leadership * Comfortable working in a fast-changing, evolving environment * Able to effectively work independently and within small groups in an entrepreneurial, development environment * Deep experience in managing regulatory vendors for large global submissions such as publishers, medical writers, data managers and auditors * Excellent written, verbal, and interpersonal communication skills and a collaborative working style. * Pursues team alignment with regulatory strategy * Effectively resources regulatory activities with plans, structures and processes for large global regulatory submissions. * Plans, develops and delivers regulatory documents that meet appropriate laws and regulations and coordinates with global MDCO colleagues. * Creates strong network and interdependencies across all teams within MDCO especially with Development Teams, quality and compliance. * Measures output against goals * Ensures regulatory activities are on time and on budget * Ensure that all materials align with MDCO quality standards (i.e. Global Code of Conduct) and messaging is compliant with all external laws and regulations. * Skilled in writing regulatory submissions utilizing appropriate technical terminology nd regulatory and medical style guides.

* Extensive experience managing global regulatory activities in a pharmaceutical and/or medical device company * Extensive technical expertise in chemistry, manufacturing and control (CMC) and device regulatory and quality systems * Minimum of 8-10 years Regulatory Affairs experience in the pharmaceutical and/or medical device industry * Experience with electronic publishing operations and medical writing * Experience with publishing of large global regulatory submissions with emphasis in CMC and quality. * Submission experience and expertise in small molecule pharmaceuticals, medical devices and drug delivery technology * BS in Science Discipline or equivalent hands-on experience

To apply for this position, please visit this Website.

Thank you,
BioTech FYI Center