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Job Description
The role is accountable for undertaking a variety of regulatory activities, under supervision, across a range of products and licensing routes for the UK market including:
1. Developing regulatory strategy and contributing to regulatory filing activities and documentation (including scientific advice and paediatric investigational plans or orphan designation), for new marketing authorisation (MA) applications and product launches. Ensures regulatory strategies are aligned with local business objectives and deliverables.
2. Ensuring life-cycle maintenance of assigned, authorised products, through timely submission of variations, renewal applications, line extensions and notifications.
3. Liaising and negotiating with the MHRA.
4. Implementing and communicating MA changes across stakeholder groups. Ensuring all compliance activities are correctly managed.
5. Generating and maintaining prescribing information, patient information leaflets and packaging components, including artwork management, and ensuring regulatory compliance with legislation and company approval systems.
6. Developing and maintaining a sound knowledge of UK regulatory legislation and guidelines to provide advice and internal expertise related to our products.
7. Representing regulatory affairs at cross-functional meetings, including new product launches, product acquisitions, and ad-hoc product issues.
8. Maintaining positive relationships with internal and external regulatory contacts.
9. Utilising and maintaining company compliance systems related to the product portfolio and meeting compliance expectations.
10. Contributing as a strong member of the UK regulatory team in departmental meetings, ad-hoc projects, and issues.
Qualifications
BSc Degree or higher (or equivalent qualifications) in pharmacy or a life-science subject.
Skills/Knowledge
* Some exposure to a regulatory affairs department would be advantageous but is not essential. Experience in the pharmaceutical industry, in regulatory, medical, or laboratory positions, is preferable.
* Excellent verbal and written communication skills are essential.
* Strong organisational and planning skills.
* Meticulous attention to detail.
* Flexibility to handle conflicting time pressures and a large volume of work.
* Ability to work independently and as part of a team, managing day-to-day regulatory activities for a product portfolio.
* Effective collaboration within the Regulatory Affairs team and with other stakeholders to achieve company objectives.
* Genuine interest and knowledge of the regulatory environment, with a desire to succeed in regulatory affairs in the pharmaceutical industry.
* Ability to identify compliance risks and escalate when necessary.
Current Employees apply HERE
Current Contingent Workers apply HERE
Additional Notes
Merck & Co., Inc. does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted without a valid written agreement will be deemed the company's property. No fees will be paid unless a pre-existing agreement is in place. Please, no phone calls or emails.
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