Senior Director, International Regulatory Affairs

Job content

Position: Sr. Director, International Regulatory Affairs

Reports to: Vice President, Regulatory Affairs

Location: preferably Zug (Switzerland) but open to other European locations

Position Summary

This role is responsible for leading the International regulatory affairs function at Apellis. Working cross-functionally within the organization in close alignment with Regulatory Affairs, Clinical Development, Medical Affairs, and Commercial, this person will work closely with the Global Regulatory Leads to develop and implement strategies and operations for obtaining product approvals and optimal labeling in the International regions (outside the United States and Canada). The Senior Director, International Regulatory Affairs will also be accountable for coordinating and directing all interactions with regulatory authorities in Europe and International markets.

The Senior Director, International Regulatory Affairs will be responsible for recruiting and managing the International regulatory team.

The Senior Director, International Regulatory Affairs will report to the Vice President of Regulatory Affairs and serve as a member of the Regulatory Affairs Leadership Team. This role also has a dotted line reporting relationship to the SVP and General Manager for International Region. The person is also a part of the International Extended Leadership Team and plays a key role in contributing to and developing the broader International strategy for Apellis.

Key Responsibilities Include

• Ensure alignment of international regulatory strategies with Apellis corporate objectives. Collaborate with key internal stakeholders to ensure the international regulatory strategy is incorporated and implemented within the stakeholder deliverables.  Communicate to regulatory team, cross-functional teams, and senior leaders the immediate to long-range plans to carry out objectives established
• Provide guidance and advice to program and project teams with respect to International market regulatory requirements and trends affecting corporate strategy, programs and processes.
• Work closely with the Regulatory Affairs team and other stakeholders to develop and implement regulatory strategies for the clinical trials and approvals of the Company’s development candidates. Leads the preparation of and provides European / International input into regulatory documents, including scientific advice briefing materials, original MAA submissions, and label extensions as required.
• As the primary point of regulatory contact for International, develop and maintain strong relationships with International regulatory authorities. Serve as the principal liaison with EMA and country Competent Authorities for original product approvals and maintenance, including negotiation and maintenance of labelling. Respond to requests for additional data, organize and manage participation in meetings. Negotiate directly with regulatory authorities regarding company’s applications.
• Develop, implement, and review current policies and practices in compliance with EU & International regulatory agencies.
• Oversees regulatory promotional compliance for European & International affiliates in collaboration with the Global Regulatory Advertising and Promotion lead
• Where appropriate/when applicable, interacts with partner companies in countries where Apellis does not commercialize directly.
• Provide input into the development and joint-oversight with Medical Affairs of early access and compassionate use programs
• Proactively anticipate and mitigate regulatory risks.
• Research and analyze regulatory information; maintain current regulatory knowledge to keep abreast of regulatory procedures, changes, and trends. Provide relevant guidance and expertise to project/program teams.
• Other duties as required.
  

Leadership Responsibilities

• Line management, professional development, and mentorship of direct reports including providing feedback on employee performance and goal setting
• Coach and train management layer of organization to be balanced, confident people managers
• Ensure that the career interests and needs of the Regulatory Affairs staff are routinely discussed and assessed to ensure talent retention
• Identify and drive strategic initiatives for employee development, process, and business improvements
• Foster and reinforce a culture of collaboration and learning that aligns with the Apellis Values
• Establish an environment of continuous iteration and process improvement through a cross-functional lens
  

Education, Registration & Certification

• BS or graduate degree in life sciences
• Regulatory Affairs Certification preferred
  

Experience

• Significant direct experience with EMA and other regulatory authority interactions, including scientific advice meetings, pre-submission interactions, MAA submissions, and post-submission negotiations and variations
• Knowledge of European pharmaceutical legislations, relevant guidelines, procedures and requirements
• Demonstrated leadership competencies in establishing clear direction and objectives
• At least 12 years of regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development (with both big and small company experience)
• Extensive experience with global regulatory processes, documents, and requirements (eg, clinical trial applications, marketing applications, meeting request procedures and materials)
  

Skills, Knowledge & Abilities

• Proven ability to lead in a fast-paced environment, enabling the team to prioritize and manage multiple competing tasks and demands while ensuring overall quality and integrity
• Enables creative problem solving, encourages unique solutions, and solves difficult problems with effective solutions
• Creates an environment that enables open, available, and transparent communication
• Strong interpersonal skill set necessary to influence and maintain internal effective and external collaborator relationships
• Facilitates productive dialogue that empowers others to share input/recommendations/perspective, while driving the group to make a decision or take a position.
• Highly developed written and verbal communication skills, including ability to effectively articulate highly technical or complex concepts to audiences with differing levels of experience
• Demonstrated ability to effectively lead, influence, and manage within a matrixed organization
• Superior leadership skills and ability to inspire, motivate and mentor teams