Ardea Biosciences, Inc., a San Diego based biotechnology company, is searching for a Sr. Manager/Associate Director, Regulatory Affairs to join the team. Interested parties can review the job description and apply on-line at: www.ardeabio.com/careers
We are seeking a Senior Manager/Associate Director, Regulatory Affairs, who will report to the Senior Vice President, Regulatory Affairs and Development Operations. The successful candidate will provide expertise in translating clinical and nonclinical regulatory requirements into practical strategic regulatory plans. Primary responsibilities include strategic planning, preparation of critical submission documentation, communications with FDA and other regulatory authorities for assigned projects.
Primary Duties and Responsibilities
Develops and implements strategies to facilitate the progress of compounds from preclinical stage into Phase 1 clinical trials through to Phase 3 and registration.
Serves as regulatory representative on selected project teams.
Serves as regulatory liaison with licensing partner(s), the FDA and other regulatory agencies, as assigned.
Reviews technical reports and summary documents (clinical, pharmacology & toxicology) for adherence to regulatory guidelines, strategies, and commitments.
Recommends regulatory policies to assure adherence to FDA and EMA requirements.
Schedules and tracks project specific and operational activities relating to the regulatory department.
Keeps abreast of all pertinent laws, regulations and guidances, and provides insight on current regulations and guidance documents relevant to product development projects; provides subsequent recommendations for regional regulatory strategies and implementation activities.
Works with Quality Assurance to provide regulatory expertise and policy support for good pharmaceutical practices (GCPs, GMPs, and GLPs).
Contributes to the modification, development and implementation of Company practices and policies related to regulatory affairs.
Prepares Regulatory Standard Operating Procedures and provides regulatory review of SOPs from other departments, as necessary.
Other duties as may be necessary.
Bachelors or Masters in a life science or relevant discipline.
Minimum eight years of broad regulatory experience.
Minimum eight years experience in the biopharmaceuticals industry.
Demonstrated ability to interface with cross-functional teams as well as external regulatory agencies.
Experience with Phase 1 through NDA submission.
Excellent writing and interpretive skills.
Must have working knowledge of ICH, FDA and EMA Clinical, Nonclinical and Multidisciplinary guidelines plus CFR 312 and 314.
Knowledge of Canadian and EU regulatory requirements is preferred.
Experience with small-molecule drug development is preferred.
Proficiency in strategizing, planning, monitoring and problem solving.
Team-oriented with excellent communication and interpersonal skills, demonstrated ability in managing indirectly.
Ability to manage multiple and diverse issues.
Strong facilitation, organizational, analytical and time management skills.
Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and MS Project.
Ability to apply knowledge to new situations.
Effective communication skills and ability to articulate complex and broad concepts and translate into plans for action and constructive improvement.
Interested parties are welcome to apply on-line at: www.ardeabio.com/careers
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