Senior Manager, CMC Regulatory Affairs - San Carlos, CA | Biospace
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Senior Manager, CMC Regulatory Affairs

Lion Biotechnologies

Location:
San Carlos, CA
Posted Date:
12/1/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
CMC, Regulatory Affairs,

Job Description


Overview
The primary responsibilities for this position encompass the Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development programs and preparation and maintenance of regulatory applications for the programs. This position will represent CMC Regulatory Affairs internally as well as in interfacing with counterparts at regulatory agencies.

Specific Responsibilities
•   Lead the CMC regulatory affairs function
•   Ensure the preparation of technically complex, high quality CMC regulatory submissions in support of development programs
•   Ensure compliance of programs with regulatory standards and commitments
•   Manage relationships with key stakeholders with responsibilities in process development, quality, analytical and across regulatory affairs to provide CMC regulatory support
•   Oversee the execution of an agreed global CMC RA strategy to support development programs
•   Actively participate as a member of Global Regulatory Team and multiple CMC-related subteams
•   Communicate complex Regulatory Affairs CMC issues and influence key stakeholders in the company
•   Stay current with regulatory requirements and initiate process improvements as appropriate
•   Analyze and exercise judgment on complex issues, guided by a thorough understanding of CMC
•   Other duties as assigned

Requirements


•   8+ years’ experience in biologics development in the US pharmaceutical or biotechnology industry, with at least 3 years’ experience in a regulatory leadership role
•   Demonstrated track record of successful management of submissions to FDA and/or other health authorities, including EMA and/or Health Canada
•   BA/BS degree in related field required (or relevant experience), advanced degree preferred
•   Specialized knowledge of CMC regulatory affairs, business principles and departmental processes
•   Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
•   Familiarity with approaches central to ensuring product quality, including the ability to identify and facilitate the resolution of CMC issues
•   Excellent interpersonal, verbal and written communication skills as well as the ability to effectively lead and influence others are essential in this collaborative work environment
•   Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities