UK Lead - Regulatory, Pharmacovigilance, and Quality & Compliance

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing biotech company with offices in Europe in Belgium (Mechelen), France (Romainville + Paris), the Netherlands (Leiden), Switzerland (Basel), Italy (Milano), Spain (Madrid), UK (London), Germany (München), and in US, Boston.

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’.

Due to our dynamic growth, we are looking for a

UK Lead for Regulatory, Pharmacovigilance, and Quality & Compliance

Scope of the job

Act as the local contact for

  • Regulatory,
  • Pharmacovigilance,
  • Quality & Compliance

with both our internal (local and global) and external (National Competent Authorities and consultants) stakeholders, ensuring full compliance with all applicable laws, regulations, and national Codes of Conduct in the UK.

The priority for 2021 is to ensure a smooth transition of all local activities and responsibilities following the marketing authorisation (MA) transfer for Jyseleca (filgotinib); a product with EMA and MHRA approvals.

Links with international headquarters will be established through a post-MA transfer strategy team, led by regulatory life-cycle management lead with representatives of Regulatory Affairs including CMC, and Regulatory Operation, Medical Information, Medical Safety, Medical Affairs Compliance, Quality & Compliance, new product introduction (NPI), and Commercial. Its’ main objective is to strategically coordinate and plan the life-cycle management.

You will report into the Medical Director UK, with dotted lines to the relevant functional heads.

Your role

  • Act as local single point of contact (SPOC) for global functions in Regulatory Affairs, Pharmacovigilance and Quality & Compliance.
  • Act as primary contact for regulatory authorities in the UK & Ireland ensuring compliance of Product Information and approval of artwork for local packaging materials.
  • Represent the company as the local contact person for Pharmacovigilance (LCPPV) and operate in close collaboration with the EU QPPV.
  • Maintain oversight of all PV related activities e.g. adverse event reporting, additional risk minimisation measures implementation, patient support programs, market research, vendor oversight, local literature review, etc..
  • Monitor all applicable laws, regulations, and national Codes of Conduct to ensure full compliance of GxP-related activities in UK & Ireland.
  • Coordinate all local GxP-related SOP trainings related to Regulatory, Pharmacovigilance and Quality & Compliance.
  • Act as the GDP-Responsible Person; ensure the implementation and maintenance of the local quality management system (QMS) including standard operating procedures (SOPs) for product recall, complaints, returns, customer, and vendor validation.
  • Achieve and maintain inspection readiness
  • Lead the local Quality Assurance Steering Committee.
  • Establish and maintain Business Continuity Plan.
  • Support the review of local promotional and non-promotional materials and activities according to all applicable laws, regulations, and National Codes of Conduct in the UK.
  • Support Finance & Global Compliance with the reporting of transfers of value (ToV).
  • Work with commercial and market access to realize cross-functional objectives.

Job requirements

Who are you?

  • A life sciences graduate, possibly with a post graduate qualification in a relevant field, who now has more than 5 years of pharmaceutical/biotech industry experience.
  • An expert on local pharmaceutical legislation and codes of conduct,
  • An efficient and effective communicator who can liaise with relevant local and global functions, including national competent authorities in the UK and Ireland.
  • A specialist in the field of GDP to be able to fulfil the task of GDP-Responsible Person.
  • An experienced coordinator of training on Regulatory PV, Quality & Compliance procedures
  • Someone with broad knowledge of PV related activities; preferably with experience as LCPPV.
  • An experienced reviewer, from a regulatory standpoint, of materials and events.
  • An individual who combines business acumen with the highest ethical standards, ensuring compliance with all applicable laws and company policies.
  • An organiser and coordinator who, when dealing with complex projects, demonstrates result-oriented, problem-solving skills.
  • A strategic thinker.
  • An effective implementer of planned activities in the UK & Ireland.
  • An influencer who can effectively negotiate and collaborate with cross functional colleagues,
  • A colleague who can be flexible, resilient, and assertive at the appropriate times.
  • A ‘self-starter’ who can drive initiatives without direct line management authority, to meet deadlines and set priorities.

What’s in it for you?

You will be part of a fast-growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos, we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

We are Galapagos: together we can make it happen…!