At a Glance
- Tasks: Manage regulatory filings and ensure compliance for new and existing medicines.
- Company: Leading pharmaceutical company focused on innovation and quality.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on process improvement and customer value.
- Why this job: Play a crucial role in bringing life-saving medicines to market quickly.
- Qualifications: Degree in medicine or pharmacy with 3 years of industry experience.
The predicted salary is between 37800 - 46200 £ per year.
- PRIMARY ACTIVITIES
- 1.
- Prepare plan and set up process for filing new medicine applications and maintenance of registration of existing company's products with regulatory authorities in timeline required.
- Notify regulatory authorities of changes to medicines.
- Maintain the process for update label based on requirement of Global for products responsible the monitoring of packaging and labeling.
- Assist in the monitoring of PV system if any.
- Assist for Product quality control together with SCM Team if any.
- 2.
- Obtain regulatory approval within optimum timelines and subsequently ensure new products are made accessible in the fastest time possible.
- Ensure immediate regulatory authority notification in relation to medicine changes.
- Help to maintain high quality and accurate packaging and labelling of company's products.
- Develop and implement time and cost saving initiatives for this role.
- Develop and implement services to assist in delivering better value to customers.
- Specific measures as per personal performance grid.
- Good collaboration with other function team for supporting business.
- Desired Experience/Education
- University graduate major in medicine/pharmacy
- Prior experience in the pharmaceutical industry at least 3 years .
- Professional Competencies Required
- Familiar with policies and procedures of Ministry of Health.
- Good working knowledge of applicable Laws and Regulations.
- Relevant knowledge of the health industry.
- Relevant knowledge of products and options.
- Competent in English language.
- Required Skills
- Collaboration, Communication, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Compliance, Regulatory Strategy Development
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
Travel Requirements
No Travel Required
Flexible Work Arrangements
Not Applicable
Shift
Not Indicated
Valid Driving License
Hazardous Material(s)
- n/a
- #J-18808-Ljbffr
Regulatory Affairs Manager 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 Manager
✨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 Manager
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.
