Director of Regulatory & Clinical Affairs

Company Information:
Our client is a biopharmaceutical / medical device company with promising products in development. This is an excellent opportunity for an industry-experienced professional in a rapidly growing company where you will be rubbing elbows with high-level scientists and open-minded individuals who are always considering new ideas.

Job Responsibilities:
Provide Regulatory Strategy and direct execution of that Strategy at a Director level. Oversee QA and provide guidance, support and ensure adherence to all areas of the (company) Quality System.
Effectively liaise, negotiate and partner with the FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support, securing the cooperation of others; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approvals.
Provide broad knowledge and experience of global regulatory affairs. Provide regulatory strategies and support that accurately interpret and reflect corporate and international regulatory guidelines for product registration.
Ability to interact effectively with senior managers other internal departments at company, FDA and externally. Ability to liaise and negotiate with FDA and worldwide regulatory agencies; orchestrate meetings and teleconferences; document interactions between company and FDA.
Collaborate with submission teams on product submissions. (e.g., IDEs, 510(k)s, NDAs, PMAs).
Prepare and project manage various submissions/documentation (e.g., IDEs, INDs, 510(k)s, NDAs, PMAs, Design Dossiers, Investigator Brochures, IFUs).
Research and prepare various export notification requirements
Oversee the achievement of objectives, to include setting a vision for others in accordance with allocated resources and timelines.
Oversee direct reports in Quality Audits, corrective action and preventative maintenance activities.
Oversee direct reports in Quality nonconformance, corrective actions and deviations to ensure timeline standards.
Accountable for compliance with QSR/GMP/GLP/EPA guidelines and applicable USP/ISO standards. REQUIREMENTS
Job Qualifications:
Advanced degree in Life Science
Experience in a pharmaceutical industry highly desired
Minimum 8+ years in regulatory affairs preferred
Minimum of 5 years of experience planning and executing clinical trials of investigational new drugs, with direct involvement in preparing, submitting and defending one or more applications for marketing authorization (NDA, BLA or equivalent).
Experience in managing CROs and other types of vendors as well as internal resources to perform all aspects of study management.
Demonstrated ability to plan and lead the growth of an evolving organization is desirable. Experience with conduct of investigational trials (Phases 1-4) in U.S., Canada, Europe and other countries are highly desirable.
Knowledge of all aspects of Good Clinical Practices (GCPs) and with U.S. and E.U. regulations governing investigational clinical trials and new product registration
Clear communication skills, written and verbal are extremely important
Able to perform multiple tasks
Excellent leadership and managerial skills
Excellent project management skills

Salary: Dependent on Experience

Location: Northern California (North of San Francisco)

For a confidential consideration please forward your resume in a Word document to [Click here for email].

Visit www.mrwg.com to view additional job opportunities available through our company.