Regulatory Affairs Senior Specialist

Job Description We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world‑class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe. An exciting opportunity has arisen in the UK Regulatory Affairs Department, for a Senior Specialist to join our team.

The department manages a broad portfolio of prescription medicines for the UK, largely across the vaccine, oncology and infectious disease therapeutic areas. This role will be based in the oncology team. This role is accountable for undertaking a variety of regulatory activities across a range of products for the UK market.

We are committed to Flexible Working, and whatever role you are in there will be options to balance your needs and the needs of the business. This will be a hybrid way of working with some time on site and some remotely or flexibility around the hours you work each day.

• Developing regulatory strategy and contributing to regulatory filing activities and documentation for paediatric submission, new marketing authorisation applications and product launches.
• Life-cycle maintenance of all aspects of the marketing authorisation’s registered particulars.
• Liaising and negotiating with the Medicines and Healthcare products Regulatory Agency Implementation and communication of marketing authorisation’s changes across stakeholder groups.
• Ensuring all compliance activities are correctly managed.
• Generation and maintenance of prescribing information, patient information leaflets and packaging components, including artwork management, and ensure regulatory compliance with legislation and company approval systems.
• Developing and maintaining a sound knowledge of European and UK regulatory legislation and guidelines to provide advice and expertise internally for matters related to our products.
• Advocates for therapeutic areas/local positions on regulatory issues and trends internally and externally contributing to a broader policy platform.
• Representation of Regulatory Affairs at cross functional meetings including product acquisitions and ad-hoc product issues.
• Utilising and maintaining company compliance systems in relation to product portfolio and meeting compliance expectations.
• Working as a strong member of the UK regulatory team, contributing to departmental meetings, ad-hoc projects and issues.
• Maintaining a positive relationship with internal and external regulatory contacts.

BSc. Degree or higher (or equivalent qualifications) in pharmacy or a life-science subject. Solid and deep knowledge of Regulatory Affairs through working in a Regulatory Affairs related role in the pharmaceutical industry. Comprehension of the fast evolving EU and UK regulatory procedures and EU and UK Medicines Legislation. Exposure to regulatory submissions and working with a Regulatory Authority would be a strong advantage.

Excellent verbal and written communication and interactive skills. Work on own initiative and take responsibility for managing the day to day regulatory activities for a portfolio of products. Work effectively within the Regulatory Affairs team and with other stakeholders to deliver on Company Objectives and Goals. Able to multitask and manage conflicting priorities with sound time-management skills. Able to demonstrate a genuine interest and knowledge of the regulatory environment and a desire to succeed in a Regulatory Affairs role in the pharmaceutical industry.

Ability to identify compliance risks and elevate when necessary

• Audits Compliance
• Drug Regulatory Affairs
• Pharmaceutical Regulatory Affairs
• Pharmacovigilance
• Process Improvements
• Project Management
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Operations
• Regulatory Strategy Development
• Regulatory Submissions

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search…