Senior Specialist Regulatory Affairs - Nordics

Senior Specialist Regulatory Affairs - Nordics

Advanz Pharma

Helsingborg, Sweden

Main purpose of role:

• As part of the EU Regulatory Affairs team, having responsibility for post-approval/life-cycle Regulatory activities in the Nordic markets (Sweden, Norway, Finland, Denmark, Iceland), for the Advanz Pharma Nordic portfolio (including Abcur AB, Amdipharm Ltd and Correvio);
• Act as point of contact with Nordics Regulatory Authorities and internal/ external stakeholders of ADVANZ PHARMA (Nordics) Office (Regulatory partners, translators, Quality, Supply Chain, Medical/PV, Commercial) for Nordics portfolio of ADVANZ PHARMA and work cross-functionally;
• Keeping an oversight of the various Lifecycle maintenance activities and provide strategic advice to the Nordics cross-functional team on regulatory matters; ensure alignment on strategies proposed/discussed with the rest of the EU Regulatory Team;
• Support Nordics teams cross functionally to ensure regulatory support when needed;
• Support the Global Regulatory Affairs New Products Team on regulatory strategies/local regulatory intelligence for new product introduction in the market as and when needed;
• Provide in-country local regulatory intelligence to wider business (including regulatory team) on new regulations/updates or by providing clarity on interpretation of existing or new regulations from the Nordics authorities;
• Coordinate review of Nordics artworks and keep an oversight of implementation; work closely with EU Regulatory and Nordics commercial team in providing clarifications around correct artworks for implementation as and when required;
• Support in review of applications to ensure correctness regarding submission category/grouping or any other local requirements based upon the Nordics regulations;
• Provide strategic and operational support for local launch activities. Work closely with the commercial team to ensure all regulatory aspects are covered to ensure launch as planned.

Key responsibilities:

• Keeping an oversight of the various Lifecycle maintenance activities for the Nordics portfolio for Advanz; coordinate with Nordics authorities to follow up on submitted applications;
• Responsible for gathering, disseminating and providing clarifications around any new regulatory guidance that may have been published by any of the Nordics authorities which may have an impact on business;
• Review of applications prepared by the EU Regulatory Team as and when needed; provide comments in a timely manner to facilitate submission to the regulatory authorities;
• Review and approval of artworks initiated by the EU Regulatory Team specifically for the Nordics markets;
• Ensure timely updated catalogue texts and regulatory information in local regulatory/supply information systems in all five countries e.g., VNR, FASS, LiiV, Farmalogg, Felleskatalogen, DKMAnet etc.;
• Maintain a strong a cooperative relationship with external Nordic partners to ensure appropriate Nordic support for eg translations and local catalogue text for all five countries;
• Ensure an oversight of labelling compliance for the Nordics products. Key driver for any such compliance projects and will project manage any regulatory submission activities by working closely with the EU Regulatory Team;
• To have an oversight of changes/variations planned and submitted, submission/approval timelines etc. Advise cross functional teams on anticipated supply risks, work closely with Supply chain and Commercial for greater alignment;
• Effectively manage to maintain a strong and co-operative relationship with all five Regulatory Authorities in the Nordic markets (Sweden, Denmark, Norway, Finland, Iceland) based on transparency, trust and clear communication. Engage with Nordics health authorities to follow up on business-critical submissions, negotiate the Company position or requesting clarifications;
• Provide support for any regulatory inspection (GVP/GDP) as applicable for the Abcur entity representing Regulatory; have a good understanding of regulatory/quality/PV processes to be able to explain them;
• Support local Commercial/Tender management /Quality/ Supply chain Management Teams through regular interactions and cross-functional work;
• Support commercial in launch preparation to ensure all local regulatory actions are performed in time for launch;
• Participate in tender submissions for management of any supporting Regulatory documentation;
• Manage communication to maintain a strong and cooperative relationship with regional CMO and external partners regarding Regulatory activities, including eg. local aspects during MA transfer applications;
• Manage Change Control/Deviation activities regarding Company MA Regulatory activities;
• Manage activities to meet external and internal compliance requirements for Company MAs;
• Manage regulatory activities for out-of-stock situations and regulatory related exemption applications in the Nordics for Company MAs;
• Ensure that all Regulatory data/documentation is accurately recorded, held and communicated with relevant internal and external stakeholders. Accountable for ensuring that the Regulatory document management system has the most current and accurate approved information for products in the Nordics portfolio.

About You:

We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients’ lives.

For this role, you will also have the following:

Knowledge, Skills & Experience:

• Fluent in English both written and spoken;
• Strategic mind-set, with ability to anticipate and plan for the future and see a broader picture; attention to detail; high quality, critical thinking, process and performance orientated; anticipates issues and implements contingency plans to avoid missed deliverables/expectations; prioritizes activities and projects, in order to better spend own time and others for what would provide the optimum return to the organization;
• Positive and ‘can-do’ approach; biased towards finding solutions and win/wins; energizes, inspires, and empowers staff. Excellent interpersonal skills, with the ability to gain respect and influence and to build lasting relationships with external experts;
• High Integrity in business and people matters; trustworthy; strong compliance and quality mind-set. He/she must have a reputation for leading with high integrity and strong work ethics.

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