Regulatory Affairs Manager Nordics

Norgine

Copenhagen or Malmö

The person holding this position will report to Associate Director and be a member of the Regulatory Affairs team.

The core responsibility of the of Regulatory Affairs Manager is to contribute to the growth and expansion of Norgine’s business through partnership with local teams within the Rx and Consumer Health Business Units and global development teams. They will also be responsible for the co-ordination, planning and interfacing with centrally driven development, lifecycle and labelling activities and through ensuring integration and launch of new assets in the Nordics and for strategic and operational oversight of all regulatory activities associated with the Nordics within the DACH and Nordics cluster and all regulatory development activities associated with those projects under his/her responsibility. They will also be acting in a capacity on behalf of Norgine Denmark A/S, Azanta A/S, Azanta Denmark A/S, Norgine AS, Norgine Sverige AB and Azanta OY.

KEY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

To be responsible for all product launches, new formulations, integrations for countries in scope;
To liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met and to proactively communicate with regulatory authorities in order to expedite approval of submissions;
To partner with local stakeholders to ensure co-ordination of approach across products and central strategic positions for country utilisation;
To be the regulatory subject matter expert in area country responsibility;
To manage and lead projects under his/her responsibility;
To represent Regulatory Affairs in the RCU leadership team;
To provide regulatory oversight for country specific submissions;
To support local Pricing & Reimbursement activities;
To provide expert regulatory input for acquisition of products pre-launch & -approval;
To provide advice and recommendations on regulatory strategies;
To provide Regulatory Intelligence, in-country and regional (EMA);
To provide regulatory support when preparing for and during GxP inspections for countries in scope;
To contribute to oversight of regulatory submissions for DACH & Nordics;
To anticipate and resolve complex regulatory issues independently;
To have budgetary responsibility and oversight for countries in scope;
To provide information on expenditure against budget for inclusion in periodic financial reports;
Where Regulatory input is required by local law or codes; ensuring promotional compliance with legislation and relevant internal/external codes within the relevant RRUs.

Requirements

Good degree in a relevant life science subject or equivalent;
Broad regulatory experience, part of which should have been gained operating at a senior level and general knowledge of worldwide regulatory requirements (including GMP);
A full strategic understanding of the drug development and life-cycle management principles and processes;
Demonstrates subject matter expertise, e.g. expertise in projects/therapy area/CMC/labelling, or country knowledge;
Ability to communicate clearly in English;
Awareness, understanding and an ability to interpret the ICH guidelines relevant to their technical/functional responsibilities, specifically for the technical/functional; responsibilities related to delivering a TPP at the end of the development process.

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