Job Title: Manager or Senior Associate, Regulatory Affairs R&D - South East
You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
Vacancy details
Vacancy description:
Job Code:
J628847
Job Title:
Manager or Senior Associate, Regulatory Affairs R&D - South East
Job Category:
Regulatory And Drug Safety
Contract:
Permanent
Discipline:
Regulatory Affairs
Country:
United Kingdom
Location:
Any Location
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
16 May 2008
Manager or Senior Associate, Regulatory Affairs - Research and Development
An excellent opportunity to work with a top global Pharmaceutical company who are currently developing a number of diverse and exciting products. Working within this large company will be an fantastic opportunity to broaden your experience, enabling you to take your next step up the career ladder!
Role:
The position will be responsible for the preparation of regulatory documentation and submissions. The Senior Associate will liaise with Regulatory Authorities, internal Research and Development Groups and external CROs as appropriate, and maintain regulatory documentation and systems.
Main Responsibilities:
• In the International Project Team setting be responsible for regulatory input into research and development projects as required
• Interpretation of Directives and Guidelines to ensure appropriate and timely development activities for required
• Successful MAA
• Provision of appropriate directives and guidelines as projects require to appropriately guide research and development activities
• Preparation of Regulatory submission documentation
Working relationships:
• Regulatory Authorities
• Company Research and Development Groups
• CROs
Qualifications and experience required:
• Degree in Life Sciences
• Extensive Regulatory Affairs experience
Skills and aptitude required:
• Attention to detail
• Good writing skills
• Good liaising skills/communication
• Diplomacy/tact
• Working with high work load and time pressures
• Computer Literacy Skills
• Understand complex issue and text
• Editorial eye
• Good interpersonal skills
Key Words: Regulatory Affairs RA Research and Development R&D Pharmaceutical Biotechnology Manager Senior Executive Senior Office Hertfordshire London North London Bedfordshire Essex West London Berkshire South East Relocatable UK Anywhere
You must be logged in to apply for this position. Log in using the form on the right, at the top of the page beneath the logo, or click here to register.
Site by Redder