At a Glance
- Tasks: Join our team to develop regulatory strategies and manage compliance for innovative medicines.
- Company: MSD, a research-driven biopharmaceutical company committed to making a global impact.
- Benefits: Flexible working options, hybrid model, and a supportive, inclusive workplace.
- Other info: Collaborative environment with opportunities for professional growth and development.
- Why this job: Be part of groundbreaking healthcare advancements that improve lives worldwide.
- Qualifications: BSc in pharmacy or life sciences with experience in Regulatory Affairs.
The predicted salary is between 47250 - 57750 £ per year.
This job is with MSD, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
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.
Responsibilities:
- 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.
Qualifications and Experience:
- 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 escalate when necessary.
Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.
Required Skills: 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.
Preferred Skills: Current Employees apply HERE. Current Contingent Workers apply HERE.
Regulatory Affairs Senior Specialist employer: MSD
MSD is an exceptional employer that champions inclusivity and diversity, making it a great place for individuals looking to thrive in a supportive environment. With a strong focus on employee growth and development, particularly in the dynamic field of animal health, team members benefit from collaborative partnerships and innovative sales strategies tailored to the unique needs of farmers in Wales. The company fosters a culture of high performance while ensuring that employees feel valued and empowered to make a meaningful impact in their roles.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Senior Specialist
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like MSD. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like MSD.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like MSD. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what MSD is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Affairs Senior Specialist
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at MSD!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show MSD that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at MSD!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At MSD, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at MSD
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at MSD that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with MSD’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
