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
1. Manage low to medium impact submission projects ensuring timely delivery of high-quality dossiers compliant with regulatory standards.
2. Support project teams with guidance on submission processes and standards.
3. Contribute to publishing timelines and participate in team meetings.
4. Coordinate multiple activities for submission projects, resolving issues proactively.
5. Work with vendors to prepare and review submission content, including cover letters and forms.
6. Perform quality reviews of published outputs, verifying content, bookmarks, links, and tables of contents.
7. Assist in developing and improving business processes and standards related to publishing.
8. Participate in internal projects to update business software and processes.
9. 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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