The Associate Director of Regulatory Affairs reports directly to the Executive Director, Regulatory Affairs. This position coordinates departmental planning, manages multiple project teams and provides the regulatory strategies to ensure appropriate implementation of key business initiatives. This position is responsible for managing submissions to FDA and other regulatory authorities for investigational and marketed products.
Contribute to the development, review, ...
Proficient with Microsoft Office software
Excellent verbal and written communication skills
Strong organizational skills
Excellent project execution skills with an ability to multitask
Can effectively and efficiently organize Regulatory Affairs and Labeling Development documentation to ensure accurate filing and timely retrieval of documents, can multi-task workload to ensure tasks are completed in a timely manner, knowledge of ...
Job Title: Agile PLM Systems Analyst
Location: Alameda, CA 94502
Duration: 3-6+ months (Strong possibility for extension)
Job Description / Requirement:
Primary Job Function
• Defines, plans & designs client area application systems requirements for new or modified applications, in the preparation of application system specifications, and in the development, testing, and implementation of efficient, cost effective application solutions.
• Specifically, has comprehensive knowledge ...
Responsible for ensuring the CMC regulatory strategy is in alignment with the global regulatory strategy and leading and coordinating the process for compiling the CMC section of regulatory submissions.
Work with cross-functional project teams to develop CMC regulatory strategy and ensure success of regulatory filings.
Reviews CMC documentation to ensures they meet regulatory requirements.
Represents RA CMC at project team meetings and coordinates regulatory workflow between ...
Job Title: Sr. Clinical Supply Chain Associate
Job Location: Novato, CA
Compensation: $85K - 100K with 8% bonus, Sign on bonus available to help with relocation costs
Work independently with minimal supervision performing end-to-end clinical supply chain management activities. Partner with the clinical team members to ensure clinical trials are appropriately supplied with product; ensure inventory levels are maintained at depots and sites. Provide study information/ ...
Looking for strong Safety Surveillance experience, must have management experience as this position will manage other staff.
Pharm.D., Ph.D. or M.D.
Minimum of 7-10 years experience with pharmacovigilance or clinical drug safety including risk/benefit analysis and safety assessment
Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
Must have excellent writing and communication skills
Global Pharmaceutical company with US Headquarters in California is looking to hire a new Manager, CMC for Biologicsbase salary starts at 100k (and goes higher - midpoint is ideal at 115, all is DOE), plus, bonus, stock, 401k, full medicala nd other LTIsRelocation available Looking for a qualified Manager (Clinical), Regulatory Affairs to manage the clin-nonclin liaison aspects of global regulatory affairs activities in support of product development. Both early and late-stage development projects ...
Global Pharmaceutical company with US Headquarters in California is looking to hire a new Manager, CMC for Biologicsbase salary starts at 100k (and goes higher - midpoint is ideal at 115, all is DOE), plus, bonus, stock, 401k, full medicala nd other LTIsRelocation availableThis position is responsible for the development, review, and management of US, EU, and International labeling for commercial products. The manager will ensure the appropriate labeling strategies are communicated to project teams; ...
Global Pharmaceutical company with US Headquarters in California is looking to hire a new Manager, CMC for Biologicsbase salary starts at 100k (and goes higher - midpoint is ideal at 115, all is DOE), plus, bonus, stock, 401k, full medicala nd other LTIsRelocation availableMUST have recent Biologics experienceThe Manager, Regulatory Affairs, is responsible for managing the CMC aspects of domestic and international regulatory affairs for commercial and clinical projects. The candidate will be ...
Start Date : ASAP End Date : 8/29/2014
Required Travel : Local Travel Required (50 Mile Radius)
Work Environment : Professional Anticipated Schedule : Typical 8 Hour/Day
Contractor Work Location : Mountain View, CA USA
Labor Category : Engineering
Job Family : Hardware/Software
Job Title : Electrical Engineer
Job Duties : Coordinates and communicates tactics with and to functional areas,Leads projects and team members ,Manages simple to ...
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