Regulatory Affairs Data Manager

Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people’s lives drives everything we do and our European experience, fully integrated infrastructure and exceptional partnership approach enables us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped 22 million patients around the world in 2020 and generated €448 million in net product sales, a growth of 7% over 2019.

Norgine has a direct presence in 12 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.

In 2012, Norgine established Norgine Ventures, a complementary business which supports innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.

NORGINE and the sail logo are trademarks of the Norgine group of companies.

MAIN PURPOSE:

The Regulatory Affairs Data Manager is responsible for:

• Day to day oversight and management of Regulatory Affairs (RA) Core Data, XEVMPD and IDMP data
• Maintaining current Subject Matter Expertise regarding RA data legislation, guidelines and requirements, interpreting impact and communicating intelligence within Norgine
• Conducting assessments of data requirements and developing plans to mitigate risks so that compliance with RA data legislation is achievable
• Partner with Associate Director, RIMS to ensure that RA Systems are compliant with RA data legislation, including IDMP requirements
• Creation and maintenance of RA data maps, processes and governance to support consistent use of RA data
• Continuous improvement of RA data models and processes

DUTIES & RESPONSIBILITIES:

• Act as Deputy for Associate Director RIM, including responsibility as Deputy RIMS Business System Owner
• Provision of RA data from RIMS to other business functions. Act as Veeva RIMS reports and dashboards expert, managing reports and dashboard requirements, development and continuous improvement
• Work with RA Managers to ensure completeness and accuracy of core RA Data
• Keep up to date on RA data legislation, including IDMP. Communicate changes to ensure RIMS Steering Committee and other key stakeholders are kept well informed of the impact to Norgine
• Participate in industry forums on data legislation. Identify and anticipate impacts of changes to RA data legislation, including IDMP
• Partner with the AD of RIMS and system vendors to ensure RA data requirements are understood and that plans are in place to select/implement/update RA systems accordingly
• Act as a SPOR Super User for Norgine RA, ensuring that SPOR processes are followed and Norgine RA data is kept up to date within SPOR
• Ensure controlled vocabularies and referentials are aligned within SPOR and applied consistently across RA systems. Ensure that changes are implemented according to best practise for data quality and standards
• Work with IT and the administrators and owners of business systems to define strategy and solve data issues. Support development of business cases as required

• Provide RA data expertise in support of data governance policies at Norgine and carry out required data governance activities
• Provide subject matter expertise to support the creation of training and educational material and deliver initial training
• Create and maintain RA data management processes, procedures and work instructions. Support continuous improvement of data and processes, collecting feedback from users and acting as subject matter expert for content where appropriate
• Conduct RA core data Impact Assessments
• Participate in Norgine RA Change Delivery Teams as required
• Maintain day to day oversight and management of Norgine’s RA data exchange activities with external agencies, including XEVMPD
• Lead data assessments, determine strategy for data transformation, migration and augmentation into Norgine RA systems. Act as project lead for these activities as required.
• Act as a mentor to other Regulatory Affairs team members, providing SME support and advice when required

Requirements

• Bachelor’s degree in Computer Science, Business Administration, or related technical field or equivalent experience.
• Significant (5-8 years) business systems / business process experience, with a minimum of 5 years experience in a Regulatory Affairs/Regulatory Operations environment. Additional experience in Manufacturing or Quality is desirable.
• In depth knowledge and understanding of regulatory data processes, legislation and standards including XEVMPD, ISO IDMP, EMA SPOR, Pharmacopeia, Standard Terms/Referentials, CMC and regulatory dossier lifecycle, MedDRA codes, etc.
• Deep understanding of the ISO IDMP data model and ability to interpret and articulate this model and legislative requirements to key stakeholders.
• Expert knowledge of regulatory and GMP documentation which will provide ISO IDMP data (e.g. SMPC, CMC and Dossier Module 3, packaging and labelling) and the processes surrounding creation, control and maintenance of these documents
• Ability to map RA data to ‘golden source’, assign functional owners and clearly communicate the data maintenance requirements to functional owners
• Experience and understanding of the use of electronic data management systems, such as regulatory publishing systems, regulatory tracking databases, and ideally, also in manufacturing, quality or pharmacovigilance systems
• Able to develop strategy and execution plans, as well as simultaneously manage multiple projects across functions
• Demonstrated client relationship skills and the ability manage self during challenging situations
• Practical operational experience of working across disciplines and across multiple regions/countries
• Strong presentation, communication skills, and follow-up skills
• Familiarity of GxP, and ideally Annex 11 and 21 CFR Part 11 computerized systems
• Excellent interpersonal skills and stakeholder management skills
• Self-motivated and able to work both autonomously and collaboratively within a team