Senior Regulatory Affairs Specialist

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Job Title: Senior Specialist Regulatory Affairs

Location: Helsingborg

About ADVANZ PHARMA

ADVANZ PHARMA is a global pharmaceutical company with the purpose to improve patients' lives by providing the specialty, hospital, and rare disease medicines they depend on.

Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with innovative biopharma and pharmaceutical development companies to bring medicines to patients.

Headquartered in London, UK, we have c700 employees based across more than 20 countries, including key countries in Europe, the US, Canada, and Australia. Our Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network complement our global operations.

ADVANZ PHARMA's product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products and pipeline cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, CNS, and, more broadly, rare diseases.

We can only achieve our ambition with the passion of our dedicated and highly qualified people, acting in line with our company values of entrepreneurship, speed, and integrity.

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.

Why ADVANZ PHARMA?

The success of any company is driven by its people, and we are no different.

At ADVANZ PHARMA, we believe in empowering our people to be entrepreneurs and embrace challenges to enable personal and company growth in an agile and fast-paced environment. We strive to do that inclusively and responsibly, treating all employees with integrity whilst rewarding outcomes and impact.

Our teams are made up of people from all walks of life and backgrounds. We thrive in an environment where uniqueness is celebrated, but we are all united by the same passion to help improve patients' lives by providing the specialty and hospital medicines they depend on.

As a business, we like to tap into new ideas and fresh perspectives. So, if you join us, you'll be empowered to own your work, explore new possibilities and make things happen.

But there's more to you – and us – than just work, which is why our culture, vision and values are so high on our agenda. We believe in gender equality and actively encourage women into senior roles – we have an active ADVANZ PHARMA Women's Network; almost 40% of our managers are women.

We work hard to recognise and reward talent, and we actively promote from within - last year, approximately 25% of our people across the company achieved promotions. In addition, we recognise talent with our annual Impact Awards, in which our top performers are rewarded for their hard work and dedication.

We offer flexible, agile working options, and you will also enjoy a highly competitive salary and benefits package.

To join us on our exciting journey, Apply now *