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:
J066738
Job Title:
Regulatory Affairs Manager
Job Category:
Regulatory And Drug Safety
Contract:
Locum/Temporary
Discipline:
Regulatory Affairs
Country:
United Kingdom
Location:
Bedfordshire, Hertfordshire, London - Central, Oxfordshire, London - North
Min experience:
N/A
Annual salary:
Negotiable
Apply by:
16 May 2008
Regulatory Affairs Manager
This top pharma company offers an unparalleled progression and has a strong presence globally. With a wide range of therapeutic areas already covered they are looking to recruit the right candidate to join their team as a Regulatory Affairs Manager.
KEY DUTIES AND RESPONSIBILITIES:
1. Initiate, manage and maintain operational activities in support of R&D auditing activities. Plan and manage complex projects and prioritize workload. May participate in the management of the budget
2. Provides direct supervision of individuals including mentoring, performance management and staffing decisions. Identifies, selects and manages the oversight of contract auditors/consultants.
3.Conduct compliance gap analysis and provide trending analysis to management. Evaluate technical and scientific information, identify deficiencies, implement and execute strategies to remediate compliance risks Maintain appropriate communication within the Global Regulatory Compliance function and other functions primarily at the project level
4. Monitor, evaluate, and interpret all applicable regulatory requirements, assure compliance with external and company standard.Assess impact of new regulations and provide feedback
5. Set team, group, or service objectives to assure they align with the compliance/regulatory strategy. Provide technical and strategic input for compliance/regulatory decisions
6. Host regulatory inspections
MINIMUM REQUIREMENTS
Education and Experience
Bachelor’s degree or country equivalent in related scientific discipline with extensive experience, Master’s with strong experience or PhD with good specific compliance experience, including managing people directly.
Essential Skills and Abilities
• Expert Regulatory knowledge
• Scientific Knowledge
• Ability to oversee multiple projects in a matrix team environment
• Demonstrated excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities
• Excellent oral and written communication and presentation skills
• Ability to accomplish results through others
• Ability to lead, coach, and motivate others
• Ability to travel
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