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- Tasks: Join a dynamic team to manage regulatory compliance and guide post-approval activities.
- Company: Be part of a growing pharmaceutical company focused on innovation and compliance.
- Benefits: Enjoy opportunities for professional growth and collaboration in a supportive environment.
- Why this job: Expand your expertise in regulatory affairs while making a real impact in healthcare.
- Qualifications: Experience in regulatory affairs is essential; enthusiasm and a team spirit are a must!
- Other info: This role offers a chance to supervise and mentor others in the regulatory field.
The predicted salary is between 36000 - 60000 £ per year.
An exciting opportunity has become available with my client, a growing pharmaceutical company, for an experienced and enthusiastic Regulatory Affairs professional wishing to expand their experience and knowledge in a growing Reg team. With a focus on post-approval activities, the successful candidate will gain exposure to many aspects of Regulatory compliance as well as the opportunity to supervise and guide a team. Responsibilities: Converting an existing application to eCTD format. Preparation and submission of Sunset clause, MA cancellation applications, MA transfers, remediation dossiers as required by the Company. Ensure completion of post-approval commitments, if any. Compilation and maintaining Product license files. Co-ordinate regulatory activities with QPPV and QP (Quality/GMP) for management of MAs. Process and communicate regulatory approvals internally and to external stake holders. Participate to the review of process/product changes, deviations, product complaints, adverse drug reactions, medical information, and batch recall to determine the need for any regulatory activities and to ensure compliance to regulatory requirements. Maintain regulatory files/database and chronologies in good order. Maintain system for tracking changes in docum…
Regulatory Affairs Officer employer: Select Pharma Careers
Contact Detail:
Select Pharma Careers Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Officer
✨Tip Number 1
Familiarize yourself with the eCTD format, as this is a key responsibility in the role. Understanding the nuances of electronic submissions will not only boost your confidence but also demonstrate your proactive approach to the hiring team.
✨Tip Number 2
Network with professionals in the pharmaceutical regulatory field. Attend industry conferences or webinars to connect with others who may provide insights or even referrals for the position at our company.
✨Tip Number 3
Stay updated on the latest regulatory changes and guidelines relevant to post-approval activities. This knowledge will help you engage in meaningful discussions during interviews and show your commitment to compliance.
✨Tip Number 4
Prepare to discuss your experience with managing regulatory files and databases. Highlight specific examples where you ensured compliance and streamlined processes, as this will resonate well with our team's focus on efficiency.
We think you need these skills to ace Regulatory Affairs Officer
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Regulatory Affairs Officer position. Understand the key responsibilities and required skills, especially those related to post-approval activities and eCTD format.
Tailor Your CV: Customize your CV to highlight relevant experience in regulatory affairs, particularly any work with post-approval processes, compliance, and team supervision. Use specific examples that demonstrate your expertise in these areas.
Craft a Compelling Cover Letter: Write a cover letter that not only expresses your enthusiasm for the role but also addresses how your background aligns with the company's needs. Mention your experience with regulatory submissions and your ability to coordinate with various stakeholders.
Highlight Team Leadership Skills: Since the role involves supervising and guiding a team, make sure to emphasize any leadership or mentoring experiences you have had in your application. This will show that you are capable of managing and supporting a team effectively.
How to prepare for a job interview at Select Pharma Careers
✨Show Your Regulatory Knowledge
Make sure to brush up on the latest regulations and guidelines relevant to the pharmaceutical industry. Being able to discuss recent changes or trends in regulatory affairs will demonstrate your expertise and enthusiasm for the field.
✨Highlight Team Leadership Experience
Since the role involves supervising and guiding a team, be prepared to share examples of your leadership experience. Discuss how you've successfully managed projects or mentored colleagues in previous roles.
✨Prepare for Technical Questions
Expect questions about specific regulatory processes, such as eCTD submissions or post-approval commitments. Familiarize yourself with these topics and be ready to explain your experience with them in detail.
✨Demonstrate Strong Communication Skills
Regulatory Affairs Officers need to communicate effectively with various stakeholders. Prepare to discuss how you have successfully communicated complex regulatory information to both internal teams and external partners.
