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- Tasks: Manage submission projects and ensure timely delivery of high-quality regulatory documents.
- Company: Join a leading pharmaceutical company in Maidenhead, dedicated to innovation and quality.
- Benefits: Competitive pay, potential for remote work, and opportunities for professional growth.
- Why this job: Be part of a dynamic team impacting healthcare while developing your skills in regulatory affairs.
- Qualifications: Bachelor's degree required; experience in regulatory affairs or related fields preferred.
- Other info: PMP and RAC certifications are a plus; flexible working environment.
Location: Maidenhead
Contract: 12 months
Hours: 37.5 hours
Rates: £20-22p/h
SRG are looking for a regulatory affairs submission associate for a pharmaceutical company based in Maidenhead. You will be responsible for establishing and maintaining submission content planners and associated timelines, facilitating tactical submission team meetings, preparing content planners for publishing, interfacing with the publishing vendor, and fulfilling Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications.
Duties and Responsibilities
- Manages low to medium impact submission projects to ensure the timely delivery of high quality dossiers that meet technical specifications defined by regulatory authorities.
- Acts as Submission Management support to project teams providing guidance and communication of established submission processes and standards.
- Provides input to project publishing timelines and deliverables.
- Participates in submission team meetings.
- Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects.
- Anticipates obstacles and proposes solutions within the team.
- Coordinates submission publishing with offsite publishers and provides notification to ensure resources are available to meet submission timelines.
- Prepares content planner for publishing and works with vendor to resolve publishing issues.
- Facilitates the creation or procurement of submission content deliverables such as cover letters and forms.
- Performs detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance.
- Facilitates team reviews.
- Contributes to the development of optimal business processes and standards within the department.
- Contributes to the implementation of internal process and standards documents relating to publishing and publishing deliverables.
- Suggests and contributes to process improvements, including changes to software and business processes.
- May participate on internal project teams to update business software.
- Demonstrates ability to influence without direct authority.
- Builds and maintains positive relationships internally and externally.
Position accountability/scope:
- Supervision required.
- Receives project assignments from manager but has responsibility for managing own projects with oversight.
- Reviews project progress with manager on a regular basis with direction provided by manager.
- May assist with onboarding staff.
Experience and Qualifications
- Bachelor's degree (Note: Years of experience may also compensate for lower education).
- PMP and RAC certificates are desirable.
Competencies
- Pharmaceutical or industry related experience.
- Experience working in a complex and matrix environment.
- Strong communication skills both oral and written.
- Experience in Regulatory Affairs preferred but may consider QA, R&D/support, Scientific affairs, operations or related area.
- Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing is preferred.
- Proven leadership skills and presence.
Regulatory Affairs Submission Associate employer: SRG
Contact Detail:
SRG 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 management and the expectations of regulatory authorities will give you a significant edge during interviews.
✨Tip Number 2
Network with professionals in the regulatory affairs field. Attend industry events or join relevant online forums to connect with others who can provide insights or even refer you to opportunities at companies like us.
✨Tip Number 3
Demonstrate your project management skills by discussing any relevant experiences where you successfully managed timelines and coordinated multiple tasks. This will show your ability to handle the responsibilities outlined in the job description.
✨Tip Number 4
Prepare to discuss how you've contributed to process improvements in previous roles. Highlighting your proactive approach to enhancing workflows will resonate well with our team, as we value innovation and efficiency.
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 skills in managing submission projects and your understanding of regulatory standards.
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 you lack formal qualifications, relevant experience can be just as valuable.
Showcase Communication Skills: Since strong communication skills are essential for this role, provide examples in your application that demonstrate your ability to communicate effectively with teams and stakeholders, especially in a regulatory context.
How to prepare for a job interview at SRG
✨Understand the Regulatory Landscape
Familiarise yourself with the current regulatory environment in the pharmaceutical industry. Be prepared to discuss recent changes in regulations and how they might impact submission processes.
✨Showcase Project Management Skills
Highlight your experience in managing projects, especially in a regulatory context. Be ready to provide examples of how you've coordinated multiple tasks and met tight deadlines in previous roles.
✨Prepare for Technical Questions
Expect questions related to submission content and publishing processes. Brush up on your knowledge of dossier preparation and the specific requirements set by regulatory authorities.
✨Demonstrate Strong Communication Abilities
Since the role involves liaising with various teams and external vendors, showcase your communication skills. Prepare to discuss how you’ve effectively communicated complex information in past roles.
