Manager Regulatory Affairs Job
King of Prussia,
Job Code - 0000085060
Position - See Job Description
Job First Active on: Wednesday, February 01, 2012
Manager, Regulatory Affairs
Excellent Opportunity for a Manager, Regulatory Affairs in King of Prussia, Pennsylvania.
This position serves as a Regulatory Affairs (RA) representative on project teams.
• Depending on the role for the Regulatory Affairs site, serves as the RA representative to the core project teams or represents the RA site as project teams for assigned projects providing regulatory support for investigational projects and market applications.
• Manages the preparation and submission of regulatory applications, reports and correspondence to regulatory agencies for assigned projects.
• Serves as FDA contact for assigned projects.
• Works with senior management and RA representatives from other sites (Bern, Kankakee, or Marburg) to assess regulatory issues as they relate to assigned projects and participate in the development of strategies.
• Monitor current and proposed regulatory and legal requirements in order to provide key regulatory advice to project teams and commercial operations for investigational and marketed products that comply with corporate and regulatory requirements.
• Role that this position reports: Senior Manager, Regulatory Affairs
Main Responsibilities and Accountabilities:
• Regulatory Affairs Representative on Project Teams:
o Work with management and Project Team members to develop strategies and advice for addressing the issues for developmental and marketed products.
o Represent the company during interactions with regulatory agencies. Makes arrangements for regulatory agency meetings (face-to-face and teleconferences).
o Prepares records of regulatory agency interactions.
• Preparation and Submission of Regulatory Applications:
o Prepare or manage the preparation and submission of regulatory applications, reports and correspondence to regulatory agencies.
o Schedule, coordinate, prepare, and review Investigational Applications (original submissions and amendments) and Market Applications (original submissions and supplements) in cooperation with the Project Team members.
o As assigned, review advertising and promotion pieces.
• Regulatory Intelligence:
o Maintain an intimate knowledge of regulations, particularly for biologics, including proposed and final rules; assure that awareness of these regulations exists within the department.
o Maintain an intimate knowledge of corporate policies and procedures as they relate to developmental and marketed products.
o Monitor current and proposed regulatory and legal issues through external meetings, workshops, and the Internet.
• Standard Operating Procedures/Local Working Practices:
o Author and maintain Standard Operating Procedures and Local Working Practices as assigned.
• Other Projects As Assigned:
o Handle non-project related projects as assigned.
BS, BA in Life Science or advanced degrees.
Regulatory Experience 5 to 7 years with 6 to 9 years of pharmaceutical or related experience
Level of Supervision: Good understanding of regulations, guidelines, and scientific principles; provides recommendations to supervisor, manages a project and or staff with minimal supervisions.
Special Training or Competence:
Must have exceptional organizational skills and knowledge of FDA regulatory requirements and ICH guidance. Interpersonal, administrative, written and verbal skills required. Requires a self-starter with the ability to work on his/her own as well as define, coordinate and direct assignments to project team members.
REQUIREMENTS - QUALIFICATIONS: Manager, Regulatory Affairs
See information above
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