contractor regulatory manager (fixed term contract)

Primary Responsibilities

• Initiate, review and approve regulatory changes through Pfizer enterprise system (i.e PDM) for changes initiated by or impacting ESOQ managed contractors.
• Provide support for the closure of the deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.
• Main point of contact for Global Chemistry Manufacturing & Controls (GCMC) dpt or Local Regulatory Affairs in Pfizer Country Offices for the regulatory activities involving the ESOQ contractors.
• As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meeting for ESOQ managed contractors and if needed, participate in Site Quality visits at the contractors.
• Support and Perform Lot Disposition for Biotech semi finished and finished products (if applicable).

Basic qualifications:

• Master’s degree in Science, Engineering, Pharmaceutical Sciences or related technical discipline
• Min. 8 years of experience in GXP setting and/or Regulatory Affairs role
• At least 4 years of Product Quality Assurance experience in a GMP environment
• Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as PDM, QTS Trackwise, Documentum platforms
• Good command of English language and multi-lingual is a benefit
• Shows strong negotiation skills and is diplomatic in communication with internal and external customers
• Strong verbal and written communication including presentation skills
• Demonstrated personal leadership to manage cross functional project
• Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor
• Able to report remotely and deliver work independently

Preferred Qualifications:

• Willing to lead by example and jump right in, desire to get to root cause, collaborative and active listener
• Effectively manages stressful situations, able to focus on task at regardless of circumstances and stress induced pressure
• Supervisory experience desirable
• Up to 10% travel if required
• Has a broad GMP and technical know-how to handle emerging issues
• Developing ability to resolve conflicts

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