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Reporting to the Director of Regulatory Affairs, the Manager of Regulatory Affairs will be a contributor in building a regulatory department. The desired candidate will possess both the depth and breadth to implement and execute on strategies that lead to global approvals of our products. The Manager will be responsible for successful execution of regulatory strategy plans. In order to be successful in this role, the person will need to be highly self-motivated, whilst possessing strong work ethic and integrity. The Manager must be articulate, an excellent communicator (both verbally and written), able to build relationships and manage to tight timelines.
The Manager has to possess the commercial gravitas to interact with key stakeholders both internally and externally.
Provides regulatory support for the projects assigned in collaboration with the regulatory lead.
· Support submissions, from planning to review - including scientific advice meeting packages, MAA , amendments, variations, annual reports etc..
· Represent regulatory in cross-functional discussion and present issues accordingly, where appropriate
· Provide guidance to teams in support of regulatory activities for International markets
· Participate in activities related to meetings with Health Authorities including preparation and coordination of Briefing packages
· Identify issues proactively that will impact programs and provide strategies to address them and communicate to the project team
· Provide insight and guidance on implementation of regulations with respect to the preparation and submission of regulatory documentation as well as the design of clinical trials
· Create regulatory submission timelines in collaboration with cross functional teams
· Provide input into regulatory development plan
· Maintains regulatory compliance of OD, PIP, MAA
Abilities Needed for Success
· Excellent attention to detail with solid organizational and communication skills, both written and verbal
· Motivation and ability to work independently and in a team environment
· Positive attitude, energetic and proactive
· Ability to provide input to review core documents
· Ability to identify and resolve regulatory issues
· Strong interpersonal skills and the ability to effectively work with others
· B.S. in a scientific discipline required
· Must have 2-5 years of relevant Pharma / Biotech Regulatory Affairs experience
· Knowledge of drug development and of the registration procedures in EU for MA
· Oncology experience desirable
· Previous Exposure to International regulatory issues a plus
· Ability to resolve conflicts and develop a course of action leading to a beneficial outcome