An exciting part time opportunity has arisen for a Regulatory Consultant to join a popular pharmaceutical company in the UK. In this role you will be expected to contribute to cross functional teams and build regulatory expertise.
- Contribute to Cross-functional Teams and Build Regulatory Expertise.
- In line with defined product responsibilities, utilise regulatory expertise to develop and deliver optimal regulatory strategies and plans to support the achievement of country business goals for both licensed and development products.
- Represent Regulatory Affairs on product based teams.
- Provide regulatory input to commercial strategic and operating planning process.
- Work with GRA regional strategists to provide country input into Global and European Regulatory Strategies as required.
- Seek to improve alignment of local and regional regulatory strategy and tactics.
- Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests.
- Manage and Submit MA Renewal Applications
- Proactively take opportunities to develop or enhance working relationships with Regulatory Authorities and trade associations.
- Develop and enact appropriate influencing strategies in order to negotiate optimal outcomes for the business on product issues.
- Liaise with clinical research project managers to seek to understand clinical research program.
- Ensure timely communication of any GCP breaches, or actions taken for safety reasons.
- Populate and Maintain Regulatory Databases
- Via defined procedures notify relevant internal customers of changes to packaging components and prescribing information the timelines for associated implementation activities.
- Prepare and submit application to discontinue product to Regulatory Authorities and notify intent to discontinue a medicine to the Ministry of Health. Act as liaison with Regulatory Authority/ministry of health.
Skills and Requirements
- Life sciences or chemistry graduate to honours level or equivalent
- Masters Degree, Post Graduate Diploma or PhD preferred
- Relevant Professional Qualifications desirable, (e.g. MSc in Regulatory Affairs)
- Previous experience and proven track record in Regulatory Affairs (Human Medicinal Products)
- Member of The Organisation for Professionals in Regulatory Affairs (TOPRA) preferred
- Computer literacy
- Excellent written and verbal communication skills
- Proven strength in analytical thinking
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.