Regulatory Affairs Officer - Top 5 Pharmaceutical company
12 months Fixed Term Contract
Salary: up to £40,000 + 10% bonus, full benefits package (private medical and dental cover, pension, 25 days holiday, etc.)
Regulatory Affairs Officer - this exciting opportunity has just become available with a leading global pharmaceutical company, on a 12 month fixed term contract basis.
Working in a friendly and supportive team, you will coordinate, prepare, submit and follow up registration applications to the UK and /or Irish regulatory authorities, to ensure that marketing authorisations are obtained and maintained in line with the company's plans and goals. You will support the launch of new products and life cycle management of the existing portfolio (with a main focus on generic medicines).
- Prepare or manage the preparation of marketing authorisation applications under supervision, to the highest possible standards within the agreed timeframe for submitting to the regulatory authorities.
- Prepare efficiently and submit responses to enquiries and deficiencies noted by regulatory authorities in connection with applications filed, under supervision, to facilitate the earliest possible approval.
- Review labelling, pack leaflets and summary of product characteristics etc. to ensure compliance with current legislation and registered particulars
- Establish and maintain effective liaison with the Medicines & Healthcare Products Regulatory Agency and /or the Irish HealthCare Products Regulatory Authority and other relevant personnel, including medical affairs, marketing, production, and research and development personnel, both within and outside the company
REQUIRED SKILLS, QUALIFICATIONS AND EXPERIENCE:
- First Degree or Professional qualification in Science, preferably Life Science or proven relevant experience within the regulatory environment.
- Experience working with generic medicines desirable
- Proven familiarity with the pharmaceutical research and development process with ability to integrate scientific information from a variety of disciplines.
- Strong written and oral communication skills
- Knowledge of basic regulatory requirements (though training provided both on the job and externally)
- Excellent time management skills and the ability to work to tight deadlines
If this role sounds of interest, please contact Tanya Georgieva at your earliest convenience.