Senior Global Regulatory Affairs Manager

Position summary

As a Senior Global Regulatory Affairs Manager, you play a key role within the Regulatory Affairs team, leading the regulatory activities for the assigned product from a strategic perspective while keeping an oversight on the CRO personnel.
You are a dynamic Regulatory Affairs professional responsible for leading the end-to-end planning, coordination, and execution of global regulatory deliverables for the assigned project. Together with the project team, you establish the regulatory submission strategy, identifying submission risks and opportunities. You provide regulatory guidance working flexibly within and across regions to ensure the delivery of business objectives to support SOTIO’s growing portfolio and assets. You are a good communicator with a can-do attitude and the ability to effectively collaborate across functions and with external collaborators.

Main responsibilities

  • Develop innovative strategies to address the regulatory requirements for the allocated programme.
  • Provide regulatory guidance to multidisciplinary teams to support CMC, nonclinical and clinical development of allocated asset(s).
  • Critically review and provide strategic input on study related documents (e.g., Investigator’s Brochure, clinical protocol amongst others).
  • Lead multidisciplinary teams (in collaboration with medical writers and regulatory CRO) in the development and authoring of major regulatory documentation such as Briefing Package, orphan designation, paediatric plans, BLA/MAA modules amongst others.
  • Lead and facilitate activities, including team preparation, for meetings with FDA, EMA, and other regulatory agencies.
  • Act as an interface with global regulatory agencies and consultants as needed.
  • Guide the cross functional team and keep an oversight on the CRO regulatory activities through the preparation, writing and maintenance of IND and EU CTA submissions.
  • Lead the cross functional team through the CTA / IND Response team activities in collaboration with the medical writers.
  • Ensure compliance of all regulatory activities including compliance with regulatory procedures and standard operating principles.
  • Support compliance activities, including development and update of internal trainings and SOPs
  • Understand the regulatory framework, including regional trends, for various types of applications and procedures focusing primarily on Europe and the US.
  • Act as a regulatory intelligence partner to leverage and benefit from the latest regulatory tools
  • Demonstrate a learning and development mindset while sharing learnings along the way as the company continues to grow.
  • Contribute to the development, structure and success of the regulatory department as well as the overall organization.

Requirements for the position

  • Education/Studies University degree in a relevant field.
  • Proven experience in a similar regulatory role is essential. Prior exposure to early development is preferred. You should be able to demonstrate expertise in EU regulatory requirements, as well as experience in the management or oversight of CTAs.
  • BLA and MAA experience is an additional asset.
  • Excellent MS Office skills are required.
  • Prior experience leading multi-disciplinary project teams internally, and contracted personnel, such as regulatory representatives at CROs are essential. You should possess an eye for detail, as well as strong written and verbal communication skills.
  • Languages: Full professional proficiency in English.
  • Location: This position is based in the SOTIO offices either in Basel, Switzerland or in Prague, Czech Republic.
  • Travel to Prague head office, health authorities and other sites may be required as per business needs, up to 20% maximum.
  • Personal qualities: You are a committed person with integrity, very good relationship skills and a proactive hands-on approach.
  • As a well-organised person, with your good overall view of various processes and requirements,you are convincing and can motivate colleagues to perform at their best, within the stipulated timelines and budget. Due to your good communication skills and experience in an international environment, you interact with various internal and external stakeholders with ease. You welcome autonomous work in a small team environment. You are a strong logical and critical thinker with the ability to analyse and propose solutions to issues that may arise.

Attractiveness of the position

The position of Senior Global Regulatory Affairs Manager offers you a unique opportunity to join the company at an exciting development stage and be actively involved in a dynamic and international environment. SOTIO is committed to science and dedicated to improving the future global wellbeing of the patient.

This is an exceptional opportunity for someone looking to be a valuable team member, who wants to develop and grow, someone who has a strategic mindset, who can work independently, as well as be an integral part of the team. This role with SOTIO offers you, as an established Senior Global Regulatory Affairs Manager, the opportunity to work in an international team environment and to make a positive impact in the organisation.

Location

This position is based in the SOTIO offices either in Basel, Switzerland or in Prague, Czech Republic.

Mám zájem Apply