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- Tasks: Manage submission projects and ensure high-quality regulatory dossiers.
- Company: Join a leading pharmaceutical company in Maidenhead, making an impact in healthcare.
- Benefits: Earn £20-22 per hour with flexible working hours and potential for remote work.
- Why this job: Be part of a dynamic team, enhancing your skills in a fast-paced environment.
- Qualifications: Bachelor's degree preferred; experience in pharma or related fields is a plus.
- Other info: 12-month contract with opportunities for professional development and networking.
About
Job Title: Regulatory Affairs Submission Associate
Location: Maidenhead
Contract: 12 months
Hours: 37.5 hours/week
Rates: £20-22 per hour
Job Description
SRG is seeking a Regulatory Affairs Submission Associate for a pharmaceutical company based in Maidenhead. The role involves establishing and maintaining submission content planners, facilitating team meetings, preparing content for publishing, interfacing with vendors, and supporting Submission Management functions across Development, Marketing, and post-marketing regulatory applications.
Responsibilities
- Manage low to medium impact submission projects ensuring timely delivery of high-quality dossiers compliant with regulatory standards.
- Support project teams with guidance on submission processes and standards.
- Contribute to publishing timelines and participate in team meetings.
- Coordinate multiple activities for submission projects, resolving issues proactively.
- Work with vendors to prepare and review submission content, including cover letters and forms.
- Perform quality reviews of published outputs, verifying content, bookmarks, links, and tables of contents.
- Assist in developing and improving business processes and standards related to publishing.
- Participate in internal projects to update business software and processes.
- Build and maintain positive internal and external relationships.
Experience and Qualifications
- Bachelor\’s degree (experience may compensate for lower education)
- PMP and RAC certifications are desirable
Competencies
- Experience in pharmaceutical or related industries, especially in complex and matrix environments
- Strong communication skills, both oral and written
- Experience in Regulatory Affairs or related areas such as QA, R&D, Scientific Affairs, or Operations
- Knowledge of Regulatory Operations and submission project management
- Proven leadership skills and ability to influence without authority
Additional Skills
- Project Management
- Publishing
Location
Maidenhead, England, United Kingdom
Work Experience
Administrative
Languages
English
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Regulatory Affairs Submission Associate employer: TieTalent
Contact Detail:
TieTalent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Submission Associate
✨Tip Number 1
Familiarise yourself with the regulatory submission processes specific to the pharmaceutical industry. Understanding the nuances of submission content planners and the requirements for compliance will give you a significant edge in discussions during interviews.
✨Tip Number 2
Network with professionals already working in Regulatory Affairs or related fields. Engaging with them on platforms like LinkedIn can provide insights into the role and may even lead to referrals, which can be incredibly beneficial when applying through our website.
✨Tip Number 3
Brush up on your project management skills, especially if you have experience with PMP methodologies. Being able to demonstrate your ability to manage multiple submission projects effectively will make you a more attractive candidate.
✨Tip Number 4
Prepare to discuss your experience with quality reviews and publishing processes in detail. Highlighting specific examples where you've ensured compliance and quality in submissions will showcase your expertise and fit for the role.
We think you need these skills to ace Regulatory Affairs Submission Associate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Regulatory Affairs or related fields. Emphasise any project management skills and your ability to work in complex environments, as these are key for the role.
Craft a Strong Cover Letter: In your cover letter, explain why you are interested in the Regulatory Affairs Submission Associate position. Mention specific experiences that demonstrate your communication skills and your familiarity with submission processes.
Highlight Relevant Qualifications: If you have a Bachelor's degree or any relevant certifications like PMP or RAC, make sure to mention them prominently. Even if your education is lower, highlight any compensating experience you have in the field.
Showcase Your Soft Skills: The job requires strong communication and leadership skills. Provide examples in your application that illustrate how you've successfully influenced teams or resolved issues in past roles.
How to prepare for a job interview at TieTalent
✨Understand Regulatory Standards
Familiarise yourself with the key regulatory standards relevant to the pharmaceutical industry. Being able to discuss these standards confidently will demonstrate your knowledge and commitment to compliance during the interview.
✨Showcase Project Management Skills
Prepare examples of past projects where you successfully managed timelines and coordinated multiple activities. Highlight your ability to resolve issues proactively, as this is crucial for the role.
✨Communicate Effectively
Strong communication skills are essential for this position. Practice articulating your thoughts clearly and concisely, both verbally and in writing. Be ready to discuss how you've built positive relationships in previous roles.
✨Demonstrate Team Collaboration
Be prepared to talk about your experience working in team settings, especially in complex environments. Share specific instances where you contributed to team meetings or collaborated with vendors to achieve project goals.
