OPTION SUISSE *** Director, Global Regulatory Lead, CardioVascular, Metabolics or Neurology *** Full relocation to Switzerland
Expiry Date: 04-10-2022
Salary: On Application
Job Type: Full Time
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About my Client:
My team and I are working for a top 20 Global R&D based Biotech company, with a solid count of well-known Marketed Products and a wide and diverse pipeline which includes Cell Therapies, mAbs, NCEs and ADCs in multiple therapeutic areas.
Currently, we are looking for an individual who is already at Director Grade or very close to it, and wants to work at the project / product level with Global Strategy and Regulatory Leadership and be the most senior RA member of the core global project team. You will be the master regulatory strategist and mind for regulatory input into clinical and regulatory strategies and lead the RA sub team lead for major submissions, including NDAs/BLAs/MAAs and New Indications. The company have several blockbusters in their therapy areas, as well as 6 NMEs in mid to late-stage development.
** This role is located in Switzerland, within an easy commute of Lausanne and Bern, and comes with a strong support package, disturbances and support for naturalization **
About the Role:
- Support the preparation of, and participate in / lead (as appropriate), key health authority (HA) interactions. Assure consistent positions on common issues are presented to global HA. Review and approve content of responses to queries from HAs for respective regions/countries
- Prepare content for regulatory strategic documentation and Regulatory Project reviews. Align regulatory plans with commercial and development plans.
- Develop target labelling and co-lead the cross-functional labelling team.
- In collaboration with the global regulatory team (GRT), develop global submission plans and Health Authority interaction plans ensuring they align with strategy liaison input...
- Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, DMC charters, IBs, DSURs, etc.
- Co-lead the cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
Degree / Experience Requirements:
- BSc degree required or a Masters, PhD, PharmD, etc. with experience of leading either US or US and EU regulatory strategies.
- Understanding of scientific content and complexities and good knowledge of cardiovascular drug development is desired.
- Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process.
- Understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies globally for drug development and approval.
- Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.
- Demonstrated ability to negotiate with and influence others. Demonstrated ability to facilitate issue resolution and conflict management. Direct experience in developing strategy and leading teams through interactions with health authorities.
- Good interpersonal skills: willingness to leverage strengths of the team and cooperate with peers in a cross-functional environment.
- Experience in successfully leading teams; Demonstrated ability to drive quality decision-making.
- Demonstrated ability to organize / prioritize tasks. Experience utilizing leadership techniques to drive a team through the stages of team development.
- Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
- Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.
- Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities.
- Experience as a member of GRTs, project working groups, or comparable experience. Experience developing strategy for product partnership (out-licensing, divestiture, co-development, in-licensing, and acquisitions).
- Demonstrates ownership of results within (and beyond) area of responsibility and holds self and others accountable for decisions and results achieved, looking for opportunities for continuous improvement.
Package & Relocation:
My client will buyout losses including stock and bonus, and they provide a decent package with a yearly stock plan which is RSUs, Share Options and a decent bonus plus they offer a full relocation package if needed from anywhere in the EU to Switzerland.
To apply for this role, please contact me Matt Greig or Javier Monfort, on +41 41 56 201 51, or press the red “Apply for position” button or send us a copy of your resume to CV@advtalent.com. We will support you throughout the interview and on-boarding process!
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