Regulatory Submissions Author
4 months ago
**Regulatory Submissions Author**
**Location: Office is based in Cambridge, but they will consider Hybrid or Remote working with occasion site visits**
**Salary: £17.00 - £20.29 per hour (depending on experience)**
**Employment Type: Full-time, 12-month contract**
**Do you hold a scientific BSc, MSc or PHD in an engineering or scientific field?**
**Do you have strong experience of working within Regulatory Submission within pharmaceutical industry?**
Our client is currently seeking a Regulatory Submissions Author to join the Biotherapeutics Pharmaceutical Research and Development Devices Centre of Excellence in Cambridge, UK.
In this role, you will be responsible for writing device-specific sections of combination product regulatory submissions. Your tasks will involve gathering and analysing data and information to populate the required documentation. Additionally, you will be expected to develop innovative approaches to streamline the regulatory submissions process, ensuring faster approvals without compromising quality and patient safety.
The role is a 12-month contract initially working full-time Monday - Friday.
**Responsibilities of the Submissions Author**
- Collaborate with authoring and product development teams to prepare device-specific sections of combination product regulatory submissions.
- Ensure all documents are completed within agreed timelines, following relevant processes and procedures, and meeting Pfizer's requirements.
- Take ownership of assigned tasks, proactively seeking input and guidance from project team members and department representatives when needed.
- Demonstrate proficiency in writing styles suitable for regulatory documentation.
- Ensure compliance with internal and external quality and regulatory standards for combination product development.
- Collaborate with drug product and device SMEs in a co-development team.
- Assist in ensuring the delivery of quality assurance.
- Liaise with external designers and contract manufacturing organizations.
**Requirements for Submission Author role**
- Bachelor's degree (BSc) in an appropriate science or engineering discipline (e.g., chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering) with a minimum of 5 years of relevant experience in pharmaceutical, device, or combination product regulatory submission authorship, particularly with FDA and EMA.
**OR**
- Master's degree (MSc) in an appropriate science or engineering discipline (e.g., chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering) with a minimum of 5 years of relevant experience in pharmaceutical, device, or combination product regulatory submission authorship, particularly with FDA and EMA
**OR**
- Doctorate (PhD) in an appropriate science or engineering discipline (e.g., chemistry, biology, biomedical sciences, mechanical engineering, materials sciences, chemical engineering) with a minimum of 5 years of relevant experience in pharmaceutical, device, or combination product regulatory submission authorship, particularly with FDA and EMA.
- Experience with electronic common technical document (eCTD) format.
- Advanced proficiency with templates and style guides.
- Ability to comprehend combination product and medical device technical terminology.
- Excellent English writing skills, capable of developing concise prose suitable for healthcare regulatory authorities worldwide.
- Comprehensive knowledge of international combination products and medical device regulations.
- Ability to work independently with mínimal supervision.
- Proficient in supervising and providing guidance to junior colleagues.
- Strong attention to technical details and accuracy.
- Capable of managing multiple responsibilities and tasks concurrently.
- Ability to adhere to strict deadlines and prioritize workload under pressure.
- Team player with excellent communication skills (verbal, written, and presentation) and interpersonal abilities.
- Proficient in general computer software, including word processing, spreadsheets, and presentations.
- If you are interested in this position and meet the requirements stated above, we encourage you to apply. Join our collaborative and dynamic team, contributing to the development of innovative pharmaceutical and medical device solutions.
**About the Company**
Our client is a well-known and respected medical and pharmaceutical manufacturer.
**About Morgan Jones**:
Morgan Jones Limited acts as an employment agency. By applying, you accept the Terms &Conditions as well as the Privacy, Cookie, and Data Retention Policy which can be found on our website.
Due to the high volume of applicants we see, if you have not heard back from us within 72 hours, please assume that you have been unsuccessful on this occasion.
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