Vice President, Global Regulatory Affairs and Pharmacovigilance

Department
Regulatory Affairs

Location
Thörishaus, BE - Switzerland

Summary Description
As a key member of the PaxVax executive team, the Vice President, Global Regulatory Affairs and Pharmacovigilance will contribute deep knowledge to proactively develop, lead, and drive the execution of the Company's regulatory and pharmacovigilance strategy from early stages through regulatory approval to launch, commercialization and product lifecycle management.

You will serve as an influential spokesperson in support of Company global regulatory initiatives and be responsible for appropriate regulatory compliance in the conduct of global development programs and product maintenance activities for the portfolio.

Reporting to the Chief Medical Officer, you will have ownership for overseeing the corporate regulatory strategy, including global regulatory submissions and associated communications with regulatory authorities. You will ensure that sound regulatory practices are fully integrated into pre-clinical, clinical and technical submissions, and will ensure that all documents submitted to regulatory agencies are appropriately reviewed, complete, scientifically accurate, of high quality, in regulatory compliance and presented in a manner that facilitates agency review.

This role will be based in Bern, Switzerland (with an option to be based in Redwood City, California).

Responsibilities:

  • Provide the Regulatory and Pharmacovigilance leadership and management required for the global development of vaccine candidates through all phases of clinical trials to licensure
  • Demonstrate leadership in the formulation and execution of global regulatory and pharmacovigilance strategies and assist with the development and implementation of policies and strategies for optimization of product development
  • Contribute to the creation and implementation of development and life-cycle management plans that incorporate regulatory strategies designed to maximize the likelihood of successful regulatory applications and delivering regulatory approval
  • Develop and maintain excellent working relationships with cross-functional executive team and provide functional area expertise and advice related to development, product support and life-cycle management
  • Monitor and anticipate regulatory, scientific and pertinent legal issues and assess potential impact on the Company; provide counsel, training and interpretation of FDA and other regulatory issues to management and teams; influence changes in guidelines and regulation to strengthen the regulatory review process and ensure core operations are proactively aligned with emerging policies
  • Act as a credible, respected spokesperson during interactions with international regulatory agencies; proactively communicate with agencies to ensure expedient and efficient review and approval of submissions
  • Develop and maintain excellent working relationships with senior staff at FDA, EMEA and other key regulatory agencies, overseeing the planning and implementation of agency meetings, as appropriate; assuring collaborative approaches to product development and clinical plans with agencies via scientific advice and protocol assessment procedures
  • Provide leadership to assure appropriate regulatory compliance in the conduct of R&D and commercial activities.
  • Oversee all regulatory filings, ranging from IND to NDA/BLA and MAA submissions to life-cycle management of marketed products, including CMC and labelling updates.
  • Attract, develop and retain a team of regulatory professionals, based in California and in Switzerland
  • Contribute to due diligence activities, as needed, for Regulatory and Pharmacovigilance areas of expertise

Requirements:

  • Bachelor Science degree required; advanced degree preferred
  • Regulatory expertise in vaccines, both pre- and post-licensure preferred
  • Knowledge of vaccines including familiarity with oral solid dosage forms
  • Expertise in global regulatory affairs and pharmacovigilance, with experience in biologics
  • Substantial experience creating, submitting, negotiating, and maintaining CTAs/MAAs
  • Track record of leading the development and execution of Regulatory and Pharmaco-vigilance strategy and ability to see the overall ‘big picture’
  • Ability to analyze and interpret complex regulatory documents and to respond effectively to all inquiries
  • Comfortable with fast moving development programs where strong collaboration is required with many different internal and external stakeholders; knowledge of development process and laws and regulations affecting the pharmaceutical industry in key jurisdictions, particularly US and European regulations
  • Direct experience leading negotiations and meetings with authorities
  • Exceptional oral presentation and written communication skills
  • Aptitude for identifying risk and working collaboratively on risk mitigation strategies with dedication to quality and patient safety
  • Experience of leading teams of global regulatory affairs associates across multiple sites and ability to influence without authority and foster positive working relationships with relevant regulatory authorities and all stakeholders
  • Demonstrated ability to lead, inspire, collaborate and drive for results with strong project management skills
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