The Sr. Director Regulatory Affairs Europe is responsible for leading the European regulatory function and for building a regulatory infrastructure to ensure regulatory support in all European countries. The Sr. Director provides leadership and direction, including developing strategies to ensure successful achievement of regulatory objectives. The Sr. Director has oversight of all regulatory-related activities related to the launch of Acadia commercial products in each of the Member States of the EU and for ensuring the implementation of post-marketing requirements following marketing authorization. In addition, the Sr. Director provides strategic input to guide development and registration plans to support successful approval of Acadia products in Europe. The Director interfaces with European regulatory agencies, corporate partners and vendors. The Director also maintains awareness of the global regulatory environment and assesses/communicates impact of changes on business and product development programs.

Primary Responsibilities

• Leads the European regulatory function and builds a regulatory infrastructure to ensure regulatory support in all European countries (initially using regional CROs and consultants as necessary)
• Participates in the European leadership team and contributes to the plans for the region ensuring all regulatory requirements are met
• Provides oversight of regulatory-related launch and post-marketing activities in the EU 
• Provides regulatory input to market access strategy and HTA plans and submissions in the EU
• Ensures regional-specific advice regarding post-marketing and promotional activities to legal, medical, and regulatory review committees
• Ensures promotional/disease awareness and internal training materials meet the requirements of the applicable EU Directives and national regulations
• Ensures product information is maintained in national databases
• Ensures all packaging and labeling requirements are met according to local requirements
• Ensures all post-marketing requirements and maintenance activities are met
• Provides regulatory input for early access programs in Europe
• Provides regulatory leadership and strategic guidance regarding European requirements for the development and registration of Acadia products
• Acts as a bridge from the European Leadership team to the US Regulatory Affairs and the Development teams to ensure that Acadia maximizes opportunities for European involvement in development activities
• Serves as a key advisor regarding European requirements
• Reviews key documents related to clinical development and registration of products and provide strategic input from a European regulatory perspective
• Leads discussions and meetings with European health authorities
• Identifies opportunities for influencing Health Authorities (via industry groups, regulatory network) 
• Leads intelligence monitoring, interpretation and implementation of EU regulations, guidelines and current environment to assure regulatory success
• Other duties as assigned

Education/Experience/Skills

Bachelor’s degree in a scientific discipline or related field; MS or PhD preferred.  The ideal candidate will have 15 years of experience in European Regulatory Affairs in the pharmaceutical/biotechnology industry.  Must have strong expertise in the European Regulatory Affairs with a proven track record of achieving successful regulatory outcomes.  An equivalent combination of relevant education and experience may be considered.

• Rare disease/orphan product experience is desirable.
• Strong knowledge of European regulations and requirements.
• Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
• Strong strategic skills including demonstrated ability to make complex decisions and willingness to defend difficult positions.
• Excellent interpersonal skills with the ability to develop relationships with key stakeholders, and good conflict management and negotiation skills.
• Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
• Strong business acumen and demonstrated ability to make sound decisions that contribute positively to the business.
• Ability to analyze complex issues to develop relevant and realistic plans and recommendations.
• Strong team player who has a customer service approach and is solution-oriented.
• Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Excellent attention to detail, written and verbal communication, and strong influencing and negotiating skills.
• Ability to prioritize and handle multiple projects simultaneously.
• Proficient in spoken and written English required.
• Ability to travel up to 20% per year throughout Europe and to the US via car, airplane, or train.

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