Manager/Senior Manager, Regulatory Affairs

Precision for Medicine are hiring a Manager/Senior Manager, Regulatory Affairs to join our team in the EU/UK.  Candidates can be based in Spain, France, Netherlands, Belgium, Germany, Italy, Hungary, Slovakia, Serbia, Romania, Poland or UK.

Position Summary:

The Manager/Senior Manager, Regulatory Affairs will lead a team of regulatory associates and provide regulatory strategy and support to assigned projects. He/She is expected to lead, support and develop assigned team members for all regulatory and ethics submissions in relation to Clinical Trials. The Manager/Senior Manager, Regulatory Affairs may lead and support teams and efforts around major filing activities to Regulatory Authorities, attend meetings, and provide regulatory support to other departments, project teams and internal initiatives as required. The Manager/Senior Manager, Regulatory Affairs maintains current knowledge of regulations and guidance documents, providing expert analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function and facilitating business development and proposals for this area.

Essential functions of the job include but are not limited to:

• Leads and develops a team of assigned Regulatory Associates
• Mentor, train and supervise staff at a functional level and supervise contract employees, as applicable
• Provides regulatory guidance throughout the clinical development life cycle
• Provides ICH GCP guidance, advice and training to internal and external clients
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
• Represent Global Regulatory Affairs at project team meetings with both external and internal customers
• Provide input, as required, into regulatory strategy and timeline development for new study opportunities. Assists in establishing company standards to ensure the highest quality of submitted information
• Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
• Keeps abreast and continually expands knowledge of laws, regulations and guidelines governing drug development and approval
• Serve as representative of Global Regulatory Affairs at business development meetings

 Qualifications:

 Minimum Required:

• Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
• 7 + years or more relevant regulatory affairs experience
• Line Management experience
• Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones
• Specialized knowledge of regulatory activities including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions
• Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
• Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied
• Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
• Able to understand and communicate regulatory requirements for pharmaceutical development submissions during the life cycle of a product.
• Availability for domestic and international travel including overnight stays
• Computer literacy (MS Office/ Office 365)
• Fluent in English

Preferred: 

• Graduate, postgraduate
• Possesses basic understanding of financial management

 Competencies

• Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities
• Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills
• Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
• Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment
• Motivates other members of the project team to meet timelines and project goals
• Flexible attitude with respect to work assignments, and new learning
• Resolves project related problems and prioritize workload to meet deadlines with little support from management
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
• Collects data of consistently high standard
• Communicates both verbally and in written form in an acceptable manner
• Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency

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