Senior Registration Officer

1 month ago

Hatfield, United Kingdom Viatris Full time

7540 Viatris UK Healthcare

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and

Partnership - Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here's how the Senior Registration Officer role will make an impact:
Key responsibilities for this role include:
New products:

- Coordinate Confirmation of Submission Strategy (CoSS)
- Provide UK national support for new product MR/DC or CP submissions managed by CRA teams
- Liaise with UK the Commercial team to support UK launches, re-launches, switches and transfers (supply chain, demand/forecasting, marketing, pricing)

Established Products:

- Provide regulatory input for designated established products to ensure legal requirements are complied with
- Prepare and submit national variations, renewals, responses to questions, or other submissions as required to the National competent UK authorities according to agreed company procedures and objectives
- Provision of relevant documentation to internal and external customers to allow the release of medical product to the market
- Ensure SPPs for UK National licences are maintained in line with company processes and guidelines
- Support other UKRA team members by reviewing data intended for national submissions and advise on any deficiencies or issues identified
- Ensure that the product registration record systems including MyPortfolio and MyIRIS are maintained
- Manage the Sunset Clause status for all UK Marketing Authorisations in line with local policy and EU regulations

Administrative:

- Ensure that periodic performance and development actions are carried out in accordance with company guidelines and timescales
- Maintain awareness of current UK guidelines and other regulatory requirements and issues
- Ensure relevant information is communicated to appropriate stakeholders within the company
- Provide updates on regulatory activities (submissions/approvals etc) to all relevant groups within designated timelines
- Ensure all appropriate company tracking tools are used and updated in accordance with specified working processes
- Review and optimize internal systems and procedures
- Manage controlled documents within the company’s Documentum based systems (DCM, D2), in line with specified working process
- Provide support for general team activities

Affiliate Role:

- Ensure that product information and artwork for designated UK marketed products are maintained within the correct system, and reflects current registered versions
- Ensure all approved UK artwork changes are implemented within specified timelines
- Liaise with Business Development (BD) for internal and third-party licences with regards to Own Label Supply (OLS)
- Update the eMC database with any changes to approved SmPCs and PILs
- Create Abbreviated Prescribing Information as requested to support Marketing team activities
- Liaise with internal UK stakeholders to ensure that systems for sharing information are robust and fit for purpose
- Ensure that agreements concerning responsibilities between UKRA and CRA teams are maintained
- Support the UK marketing team by is reviewing promotional material line with internal and national requirements
- Assist with the implementation of UK risk management plan activities
- Represent UK regulatory affiliate at regulatory meeting with internal and external stakeholders, e.g., product launch meetings, UK commercial management meetings, BGMA, PAGB etc.
- Maintenance of the MIA and WD licences
- Assist with company audits (internal/external) as appropriate

Training/Mentoring / checking role
- Provide support to other UKRA team members as required
- Provide cover for other UKRA team members during their absence
- Deputise for PRO(s) as requested
- Assist other UKRA team members produce documentation and submission dossiers of an acceptable standard
- Assist other UKRA team members to meet agreed KPIs for company procedures and objectives

The minimum qualifications for this role are:

- BSc or equivalent in Life Sciences or related area.
- Demonstrable experience in Regulatory Affairs.
- Effective verbal and written communication skills.
- Proven experience in managing large volume and fast paced product portfolios.
- Flexible approach to enable prioritisation in line with company requirements.
- Proven ability to effectively participate in working groups or cross functional project teams, and successfully collaborate with colleagues.

At Viatris, we offer competitive salaries, benefits and an inclusive environm

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