Reference Number: JO-1910-438715
Senior Regulatory Manager
Job Type: Permanent
Senior Manager, Regulatory Affairs and Pharmacovigilance
Philadelphia, US Home Office flexibility
Excellent Salary and Benefits
Regulatory Professionals are currently working with an exciting CRO based in Philadelphia who are looking for a Senior Regulatory Manager to lead US-based projects in the regulatory department, providing regulatory expertise and guidance to clients and to the internal team.
Their focus lies in the development and the commercialization of medicines globally, regionally, and nationally. They drive pharmaceutical and biotech product development from first into man right the way through to the end of the product lifecycle.
To provide effective consultancy and support for client projects and support the development and management of key client accounts.
Manage day-to-day pharmacovigilance & regulatory affairs activities to ensure compliance with regulatory obligations and requests.
Provide advice on US FDA regulatory strategy and requirements for investigational and marketed products to pharmaceutical and biotechnology clients.
Provide regulatory advice in support of global clinical study programmes with an emphasis on identifying areas for harmonisation of regional requirements.
Participate in client meetings and liaise with clients regarding ongoing projects.
Prepare, coordinate and review documents in order to support regulatory submissions for both investigational and commercial medicinal products, including safety submissions.
Liaise with the FDA including the organisation of agency meetings and associated briefing materials
Ensure compliance with US regulatory requirements including contribution to client and/or the companies quality systems
Bachelors degree is required. A Life Science degree is preferable.
Extensive pharmaceutical industry experience in an US regulatory environment and ideal pharmacovigilance.
Solid knowledge and understanding of US Regulatory Affairs legislation and procedures. Knowledge of additional regional requirements.
At least 7+ years working in a CRO environment (preferred) or within the pharmaceutical industry.
Experienced working with clients and prospecting business preferable
Experience working with small biotech companies would be advantageous.
Experienced writer of scientific/technical documents across the entire product lifecycle. A strong technical background (CMC/NCx/Cx/R&D) would be advantageous.