Head of Regulatory Affairs

If you are looking to be a part of a dynamic, global, fast-growing organization, have a positive attitude, willing to develop yourself, and are energized by being a part of improving the health of others, we are the perfect match for you. By joining us as the Global Head of Regulatory Affairs your position will be broad, communication between departments will be fast and effective and you will have significant responsibility and autonomy for your work and contributions.

As the Global Head of Regulatory Affairs working on the Global Regulatory Affairs team you will be empowered to develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and multiple projects.

Principle Responsibilities:

• Oversees regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan. Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of all regulatory projects. Ensures compliance for global regulatory requirements.
• Is a leader, contributing to cross-functional initiatives and influencing as applicable and demonstrating leadership behaviors.
• Directs and oversees multiple projects (inclusive of highly complex ones), generally has global/regional oversight for assigned products, this includes oversight to ensure regulatory compliance (e.g. on registration database) by staff and / or vendor.
• Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility. Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications.
• Provides leadership and development for direct reports, including those that serve as regional regulatory leads responsible for the design and execution of regional regulatory strategies.
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
• Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
• Accountable for all global submissions and approvals of project(s) and/or oversees direct reports responsible.
• Oversees all submissions.
• Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and / or vendor; negotiates on behalf of RA team, as necessary.
• Accountable for working with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided in compliance with local regulations. And to maintain compliance for products.
• Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.

Qualifications and Education Requirements:

• MD, PhD or PharmD in a scientific discipline preferred along with 15+ years of experience in Regulatory Affairs
• Proven success in regulatory submissions.
• FDA, EU, Canada, ROW, and post-marketing experience is a plus with sound knowledge of such principles as GxP's, FDA, and EU guidelines.
• Previous experience in attending and leading a team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.)
• Experience with investigational drugs, including late stage development, and marketed products
• CRO management experience preferred.
• Prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals, is highly desirable
• Must be a strong leader that creates a vision for group. Inspires and motivates group. Takes stand on important issues in productive, respectful way. Able to mentor and develop skills of staff.
• Must be strong overall and able to train/develop staff in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
• Strategic thinker, planner, and implementer with excellent organizational skills.
• Excellent oral and written communication skills and knows how to present data/issues both to a technical and non-technical audience with the ability to write and edit regulatory documents.
• Able to plan and execute regulatory projects, and proven record of delivering results within business-defined timeframes.
• Proven ability to work on complex problems where analysis of the situation or data requires an evaluation of intangible variables.
• Demonstrates potential for a high level of collaboration with others and within global teams.
• Independent thought, negotiation skills, integrity, and adaptability.
• Ability to work on own and in virtual setting.
• MS Office skills with excellent use of excel, PowerPoint and MS Project required.
• Recent experience with a smaller entrepreneurial environment is a definite asset.
• Fluent in English (written and oral).

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