Sr. Regulatory Program Manager

Piper Companies is currently looking for an experienced Sr. Regulatory Program Manager to work remotely (East Coast Preferred) for a leading pharmaceutical company. The Sr. Regulatory Engagement Manager will play a significant role in leading company adherence to eCDT 4.0 regulatory requirements.

Responsibilities for the Sr. Regulatory Program Manager include:

·      Lead a top 30 pharmaceutical organization in compliance efforts with eCDT 4.0 regulatory changes

·      Utilize consulting skillset such as Program management, Process modeling, process optimization, change management and vendor management to oversee full project life cycle

·      Act as subject matter expert on regulatory operations, eCTD 4.0 regulations, including transition to eCTD 4.0, IDMP awareness, submission planning/tracking, and forecasting

·      Lead project communication with local project team, internal stakeholders, international UK based company representatives and vendors

Qualifications for the Sr. Regulatory Engagement Program include:

·      A minimum of 8+ years within pharmaceutical manufacturing regulatory affairs

·      3+ years of project management leading regulatory initiatives within pharmaceutical development and manufacturing

·      Hands-on experience implementing eCDT 4.0 regulatory changes

·      Hands on experience with Veeva systems

·      B.S. in regulatory affairs or related field required

Compensation for the Sr. Regulatory Program Manager include:

·      Compensation range is $90.00/hr – $100.00/hr dependent upon experience

·      Comprehensive benefits package

Keywords 

Sr. Regulatory Program Manager, Regulatory Affairs, Project Management, Program Management, eCDT 4.0, Regulatory Compliance, Pharmaceutical Research, Pharmaceutical Manufacturing, Science, comprehensive benefits package, Health, Vision, Dental. #LI-ONSITE #LI-DF1