Senior Director, EU Regulatory Affairs

Regulatory Affairs Zug, Switzerland


Description

Position Summary:

This role is responsible for establishing and managing the European regulatory affairs function at Apellis. Working cross-functionally within the organisation in close alignment with Regulatory Affairs, Clinical, Medical Affairs and Commercial, this person will work closely with product teams to develop and implement strategies and operations for obtaining product approvals and optimal labeling in Europe. The Senior Director, EU Regulatory Affairs will also be accountable for coordinating and directing all interactions with regulatory authorities in European markets.

Although initially a standalone position, the Senior Director, EU Regulatory Affairs will eventually be responsible for recruiting and leading a European regulatory team.

The Senior Director, EU Regulatory Affairs will report to the [General Manager, Europe], with a matrix reporting relationship to the Vice President of Regulatory Affairs.  The person is also a part of the European Commercial Leadership Team and plays a key role in contributing to and developing the broader European strategy for Apellis.

Responsibilities:

  • Provide guidance and advice to program and project teams with respect to European market regulatory requirements and trends affecting corporate strategy, programs and processes
  • Work closely with the Vice President of Regulatory Affairs and other stakeholders to develop and implement regulatory strategies for the clinical trials and EU approvals of the company’s development candidates. Leads the preparation of and provides European input into regulatory documents, including Clinical Trial Applications, Investigational Medicinal Product Dossiers, scientific advice briefing materials, original MAA submissions, and label extensions
  • As the primary point of regulatory contact for Europe, develop and maintain strong relationships with global health 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 regulatory agencies. Monitor regulatory trends and anticipate key developments in European markets; assess potential strategic impact and take necessary action
  • Oversees regulatory promotional compliance for European affiliates
  • Where appropriate/when applicable, interacts with partner companies in countries where Apellis does not commercialise directly
  • May be responsible for line management and development of direct reports
  • EAP/CUP: input in the development and joint-oversight with Medical Affairs of early access and compassionate use programs

Qualifications:

  • B.S. or graduate degree in life sciences
  • At least 10 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)

Skills, Knowledge & Abilities:

  • Strong knowledge of current EU regulations, including specifically special programs for rare diseases and unmet medical needs (eg orphan drug designation, PRIME). Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance - preferably from at least both EU and US.
  • Experience with developing and implementing competitive regulatory strategies
  • Demonstrated track record in securing product approvals and maintaining a complex portfolio
  • Direct experience of leading regulatory authority meetings in different phases of drug development
  • Experience dealing with broad range of stakeholders at all levels internal and external to the company

Physical Demands and Work Environment:

This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary.

This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!  Visit http://apellis.com/careerbenefits.html to learn more.

Company Background:

We are a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade. We believe that this approach can result in broad inhibition of the principal pathways of the complement system and has the potential to effectively control a broad array of complement-dependent autoimmune and inflammatory diseases.

Visit http://apellis.com/about.html to learn more.

EEO Statement: Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumocononiosis or any other characteristic protected under applicable federal, state or local law.