Regulatory Affairs Executive, Systems & Operations
- Hiring from
- United Kingdom
- Work type
- Hybrid
- Posted
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Competitive Salary & Company Benefits| Ideally located close to Petersfield. Monday to Friday, 9.00am - 5.00pm (potential for flexibility on start/end times based on 7.5hrs/day)
Are you looking to work for a rapidly growing UK Pharmaceutical company, who are passionate about improving patients’ lives across the world?
Aspire Pharma is an asset-light pharmaceutical manufacturer. It licenses and develops niche pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets which are often underserved. The business has a highly diversified portfolio of more than 250 products across a number of categories, including branded specialty products and unbranded niche generics in therapeutic areas such as urology, ophthalmology, CNS and dermatology.
Do you want to be part of the journey?
If so, here is your chance!
The Role
We are currently looking to recruit a Regulatory Affairs Executive, Systems & Operations to support the Regulatory Systems and Operations team in managing the logistical and administrative aspects of regulatory information systems and electronic regulatory submissions.
This role focuses on the compilation and publishing of regulatory applications, coordinating eCTD submission components, and assisting with the maintenance and archiving of regulatory documents.
The Regulatory Affairs Executive, Systems & Operations ensures compliance with regulatory requirements for submissions and supports the overall efficiency of regulatory operations.
Are you looking to work for a rapidly growing UK Pharmaceutical company, who are passionate about improving patients’ lives across the world?
Aspire Pharma is an asset-light pharmaceutical manufacturer. It licenses and develops niche pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets which are often underserved. The business has a highly diversified portfolio of more than 250 products across a number of categories, including branded specialty products and unbranded niche generics in therapeutic areas such as urology, ophthalmology, CNS and dermatology.
Do you want to be part of the journey?
If so, here is your chance!
The Role
We are currently looking to recruit a Regulatory Affairs Executive, Systems & Operations to support the Regulatory Systems and Operations team in managing the logistical and administrative aspects of regulatory information systems and electronic regulatory submissions.
This role focuses on the compilation and publishing of regulatory applications, coordinating eCTD submission components, and assisting with the maintenance and archiving of regulatory documents.
The Regulatory Affairs Executive, Systems & Operations ensures compliance with regulatory requirements for submissions and supports the overall efficiency of regulatory operations.
Knowledge & Skills
Technical and/or Professional Qualifications and Experience
- Organisational Skills: Excellent organisational skills and attention to detail.
- Communication: Strong written and verbal communication skills.
- Collaboration: Ability to work effectively as part of a team and take direction.
- Learning Agility: Eagerness to learn and adapt to new regulatory requirements and processes.
- Analytical: Basic analytical and problem-solving skills.
- Software Proficiency: Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
Technical and/or Professional Qualifications and Experience
- Bachelor's degree in a scientific discipline
- Experience in Regulatory Affairs, Quality Assurance, or a related field within the pharmaceutical or biotechnology industry.
- Familiarity with regulatory documentation (e.g., CTD structure) and good understanding of electronic submission concepts.
- Experience with document management systems and/or regulatory publishing tools.
- Good knowledge of GMP principles.
What will you be doing?
Electronic Submissions & Publishing Support
Electronic Submissions & Publishing Support
- Assist in the compilation, formatting, and publishing of various regulatory applications, including eCTD components.
- Support the coordination of eCTD submissions by gathering, checking, and organising documents from authors and other regulatory teams.
- Perform technical validation checks on submitted documents to ensure compliance with eCTD specifications.
- Assist in the dispatch and tracking of electronic submissions to health authorities.
- Ensure all documents are correctly hyperlinked and bookmarked according to submission requirements.
- Support the day-to-day maintenance and operational use of regulatory information management (RIM) systems and document management systems.
- Assist in user support and training for functionalities of regulatory systems.
- Perform data entry and ensure data integrity within regulatory databases.
- Help troubleshoot system issues and escalate more complex problems to senior team members or IT.
- Assist in the archiving of regulatory documents and submissions, ensuring they are correctly indexed and stored.
- Support the retrieval of archived documents as requested by internal stakeholders.
- Help maintain regulatory repositories and ensure document accessibility.
Compliance & Quality Control
- Ensure all assigned tasks comply with current global regulatory guidelines (e.g., eCTD specifications) and internal SOPs.
- Perform quality control checks on regulatory documents and submission components for accuracy and completeness.
- Support the implementation of new processes and procedures within regulatory operations.
- Work collaboratively with other Regulatory Affairs teams (CMC, Labelling), IT, and Quality Assurance to facilitate smooth regulatory processes managed by the core Regulatory teams.
- Communicate effectively with senior team members regarding project status and operational issues.
- Participate in internal team meetings, contributing to discussions and learning about regulatory operations.
Why join us?
As well as a fantastic, inclusive company culture where employees are truly valued, and a competitive salary, we also offer an ever-improving benefits scheme to support your physical and mental well-being which include:
If you think you are suitable for this role, please apply now!
As well as a fantastic, inclusive company culture where employees are truly valued, and a competitive salary, we also offer an ever-improving benefits scheme to support your physical and mental well-being which include:
- Company pension scheme.
- 2 Corporate Social Responsibility (CSR) days per year.
- Life Assurance cover and Employee Assistance Program.
- 25 days’ holiday plus bank holidays.
- Learning and development opportunities.
- Excellent opportunities for progression.
- Fantastic company events and celebrations throughout the year.
- Cycle to Work Scheme
- Private healthcare schemes
If you think you are suitable for this role, please apply now!
