Regulatory Affairs Officer

4 days ago

Cambourne, United Kingdom Aspire Pharma Ltd Full time

Regulatory Affairs Officer 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.
In October 2022, Aspire Pharma and H.I.G.
Capital completed the transformational acquisition of Morningside Pharmaceuticals and Healthcare who has a diversified portfolio of more than 100 products across a range of therapeutic areas.
As these two successful businesses continue the integration process, it is a truly exciting time to join this growing business.
This acquisition will create a clear leader in the UK specialty pharmaceuticals market and a platform ready to drive rapid international expansion through both organic and inorganic approaches.
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 Officer to join our high performing Regulatory Affairs team based in Petersfield.
What will you be doing?
Submission, maintenance and control of regulatory information and documentation for medicines, medical devices, and other products Compilation, review and submission of new product dossiers and technical files (including own development, in-licensed and out licensed) and all aspects of regulatory lifecycle maintenance for existing products.
Ensure all submissions to regulatory authorities are of high quality and all correspondence is conducted in a professional and timely manner.
Authorship and/or review of technical documentation, including product artwork, for alignment with applicable regulations and guidance and assessing suitability for submission where appropriate.
Preparation and update of registered information for third parties to ensure products can be manufactured and released in accordance with the approved regulatory information.
Responsible for quality, maintenance, control and distribution of internal sources of regulatory information.
Internal and external liaison 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.
an understanding of the impact of regulatory changes on the rest of the business and ensure changes are communicated appropriately.
Due diligence Regulatory due diligence of new products using knowledge of current regulations and guidance.
Project management Understand and manage workload for assigned projects in line with business priorities.
Communicate workload concerns with line manager and other team members.
liaise with internal and external stakeholders regarding issues relating to projects.
Compliance Awareness of existing and new legislation/guidance relating to EU, UK and RoW (as required) GxP; Medicines; Medical Devices including all ISO activities (including ISO13485 and ISO14971); Controlled Drugs; Nutritional Products; In Vitro Diagnostic Devices; Biocidal Products; and General Data Protection Regulations and the UK Data Protection Act, as required.
Regulatory Intelligence Maintain awareness of new and existing legislation and guidance from regulatory competent authorities.
The Person A robust science degree, relevant to working in the Pharmaceutical Industry.
1-2 years regulatory experience (preferred) A really strong ambition to build a career in this sector.
A can-do, problem-solving attitude.
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.
Free parking, tea, and coffee.

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