Reg Affairs Mgr
Manages a regulatory and/or technical project, for both internal and external clients, as appropriate. Provides strategic regulatory and/or technical consultancy on a variety of projects.
- Acts as a Lead Regulatory Professional on any type of writing or technical project, with limited guidance from senior staff using experience and initiative to generate new and unusual document types to meet customer requirements.
- Provides strategic regulatory and/or technical consultancy on a variety of projects and provides senior review and guidance for most documents prepared by junior colleagues.
- May act as a Project Manager for a stand-alone project, with full project management responsibility.
- May prepare a single service regulatory or technical proposal for senior review and/or propose budgets for less routine projects, out of scope activities and potential budget efficiencies. Deliver business development presentations to customers with confidence and detailed knowledge, as directed.
- Independently meet with customers face to face to discuss project status. Identifies creative solutions to challenges that are acceptable to Quintiles and customers, thereby consistently receiving positive customer feedback.
- Ensures compliance with regulatory processes, ensuring readiness for internal or external project audits.
- May design training materials and deliver training externally and internally.
- May represent region or site on a regulatory, technical or cross functional Initiative.
- Performs other tasks or assignments, as delegated by Regulatory management.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Extensive experience in regulatory and/or technical writing
Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers
Strong software and computer skills, including MS Office applications
Sets a positive example to more junior colleagues relating to a professional manner, positive attitude and communication style with customers and colleagues
May take calculated risks when making decisions, seeking guidance from Regulatory management, as appropriate; demonstrates autonomy and initiative, as appropriate
Ability to earn respect from peers in other operational groups
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
- Degree in life science-related discipline or professional equivalent plus at least 6 years relevant experience* including 4 years regulatory experience or high school diploma plus 10 years relevant experience* including 6 years regulatory experience (*or combination of education, training and experience)
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Travel will be required
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