Re­gu­la­tory Affairs Com­pli­an­ce Manager

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 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 minds together and provide world-leading tools and resources in a unique structure that fosters real agility and entrepreneurial spirit.

About this job:

Reporting into the RA lead for the Nordics, this role will focus on the Regulatory compliance activities across the Nordics cluster for assigned products. This will involve the timely preparation, submission, conduct and follow-up of new Marketing Authorization and Life Cycle Management applications to the national competent authorities. This position will provide regulatory guidance to multidisciplinary teams in order to meet regulatory demands (legislation and guidelines) and ensure high quality labelling translation and compliant printed packaging materials of marketed products. Part of the focus of this role will also ensure RA stays updated on relevant EU and local regulations and guidelines. Key activities for this role are noted below:

  • Support implementation locally of new initiatives, management tools or processes ensure that processes, procedures and regulatory files are well documented in up to date
  • Contribute to the EST-RA and affiliate Quality Management System. Ensure compliance with all applicable SOPs, WPDs and STLs and contribute to CAPAs in case of gaps and deviations.
  • Secure timely and adequate information and decision making regarding regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions.
  • Take part in affiliate product and launch teams to provide regulatory input and strategy advice.
  • Take part in assigned working groups of local trade association networks and liaise with local agencies, pharmaceutical organization and other stakeholders
  • Monitor, apply and communicate local regulatory intelligence in all extend within RA-EST and within the affiliate.
  • Align strategic and operational RA activities in the commercial business (Marketing, Sales, Market Access & Pricing and Logistics) in order to anticipate and plan product registrations and launches.
  • Comply with the change control process for Marketing Authorizations and execute the up to date EST-RA planning
  • Develop registration strategies for assigned projects and develop processes for the improvement of registration timelines
  • Submit quality, new marketing authorisations and related regulatory submissions (e.g. variations, PSURs, renewals) to the authorities.
  • In connection with submission of MA applications, variations and renewals etc provide translation and QRD check of Product Information and ensure quality assurance including linguistic check of these documents.
  • Communicate about submitted and approved Summary of Product Characteristics (SmPC) or/and the leaflets and make these available for internal and external (if applicable) use
  • Submit and implement Risk Minimization Plans and additional Risk Minimization Measures conform internal and external guidance.
  • Provide regulatory support for tendering processes.
  • Communicate approvals of regulatory submission to the right stakeholders in the right way and with the right timing. Stakeholders include, but are not limited to internal and external databases, repositories and trackers.
  • Manage artwork (printed packaging components) creations and approvals in a consistent and compliant way using the artwork management system. Proofread artworks accurately. Monitor of implementation in production.
  • Upon request, provide regulatory support for GxP Inspection teams.
  • Review and approve (abbreviated) prescribing information and promotional materials as mandated by Astellas procedures and country legislation.

Essential knowledge & experience:

  • Knowledge from within pharmaceutical Industry is preferable, in a regulatory, Ethics & Compliance or medical position.
  • Understanding or knowledge of Regulatory landscape within the Nordics is
  • Proficiency in local and English language, able to communicate effectively verbally and in writing
  • Strong organisational and planning skills with meticulous attention to detail
  • Able to work independently and within a team and manage multiple activities

Education/qualifications:

  • MSc Degree in Pharmacy or other Life Science subjects or equivalent by experience.

Additional information:

  • This is a full-time permanent position based in the Denmark

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.

Gem job

Astellas Pharma A/S
Publiceret: 20. oktober 2021

Arbejdssted

Home office