General Information

Job Advert Title
Regulatory Affairs Manager - Fixed Term Contract
Location
United Kingdom
Function/Business Area
Regulatory Affairs
Department
Regulatory Affairs and Quality
Employment Class
Fixed Term Contract

Description

Regulatory Affairs Manager – Fixed term Contract (12 months plus)

About Astellas:

At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.

About This Job:

The Astellas UK/IE affiliate Medical Regulatory Affairs team have an exciting opportunity for an aspiring Regulatory Affairs Manager with ABPI final signatory status to join the team and take responsibility for the regulatory review and approval (sign-off) of (abbreviated) prescribing information and promotional materials are conducted as mandated by Astellas procedures and UK and Irish legislation. The successful individual will maintain a high level of expertise about UK and EU regulatory procedures and requirements with a focus on advertising codes, ensure that local regulatory intelligence to full extent is monitored, applied and communicated within RA-EST and within the affiliate. This could also lead to an opportunity to permanently join the team.

Specifically, you will:

  • Participate in brand teams, representing regulatory affairs in cross-functional meetings e.g. brand planning, launch meetings.
  • Drafting and updating RA quality documents (SOPs) or guidance document
  • Training other shareholders on main learnings from MHRA vetting process or other topics related to promotional review.
  • Organizing cross-functional meetings with promotional material reviewers when needed (i.e. risk assessment).
  • Understand and interpret scientific data and make recommendations
  • Under guidance from the RA Lead & by other team members, ensure timely preparation, submission and follow up of variations, renewals, amendments and other regulatory applications to ensure maintenance of marketing authorisations.
  • Ensure current regulatory product information is available to internal and external stakeholders at all times.
  • Assist with preparation and maintenance of artwork as required for marketed products using relevant systems.
  • Ensure SmPCs are maintained and relevant notifications are made in a timely manner according to local processes.
  • Produce regular overviews for relevant personnel of upcoming variations that impact on company product information.
  • Receive regulatory related Astellas global and regional policies and SOPs and maintain training compliance.
  • Back up for maintenance of external databases necessary for operation of the department (i.e. eMC/, C & D, In Demand) as well as stock notifications to DoH.
  • Under guidance from RA Lead and other RA staff, ensure company databases are maintained as required (e.g. Vault, EAGLE, Trackwise)

Essential Knowledge & Experience:

  • Experience as a qualified medical signatory
  • Experience within a relevant Pharma medical function such as Medical Advisor or Regulatory Associate.
  • Demonstrable clear communication & collaboration within a team, cross functionally and above country.

Educations/Qualifications:

  • Medical doctor or registered pharmacist in order to comply with requirements for medical signatory.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.