Regulatory Affairs Officer

1 month ago

Braunstone Town, United Kingdom Aspire Pharma Limited Full time

Competitive Salary & Company Benefits| Leicester or 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 Responsible for the regulatory affairs activities of the company, including maintenance and compliance of approved products, including contact with the relevant stakeholders for information as required to ensure timelines are adhered to, to meet business needs.
Working with different departments to compile, publish and submit new product dossiers and technical files in the UK, EU and RoW as required by the business.
Maintain an awareness of current regulatory and GxP requirements to advise on opportunities and threats to the product licenses, development and regulatory strategies.
Perform such duties, with comparable level of responsibility, as may be required, in the interests of the company.
What will you be doing?
Submission, maintenance and control of regulatory information and documentation for medicines, medical devices, and other products.
Act as first point of contact for third parties (e.g.
contract manufacturers/research organisations), regulatory agencies and internal departments for specific issues relating to products.
Coordinate with internal and external stakeholders to prepare responses to requests for information from regulatory authorities within stated timelines.
Assist with regulatory due diligence of new products using knowledge of current regulations and guidance.
Proactively liaise with internal and external stakeholders regarding issues relating to projects.
Maintain awareness of existing and new legislation/guidance relating to EU, UK and RoW.
Maintain awareness of new and existing legislation and guidance from regulatory competent authorities.
The Person Degree in a scientific or similar discipline.
Good interpersonal and communications skills.
Highly organised with good attention to detail.
Proficient in Microsoft Office packages such as Word, Outlook, PowerPoint, Excel and also have the ability to learn other in-house programmes (SharePoint).
Task orientated and diligent.
Scientific writing.
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: Generous Pension Scheme.
Life Assurance cover and Employee Assistant Program.
25 days holiday plus Bank Holidays.
Learning and Development opportunities.
Excellent opportunities for progression.
Fantastic Company events and celebrations throughout the year.
ADZN1_UKTJ

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