Regulatory Affairs Director

Location
MD, USA
Salary
Competitive
Posted
Nov 09, 2017
Closes
Dec 20, 2017
Ref
1185972463
Contract Type
Full Time
**Description:**

**PURPOSE**

Direct, oversee and manage large, complex, regulatory projects, ensuring quality deliverables on time and within budget. Has strategic decision-making responsibility for the project/program. Ensure that all project work is completed in accordance with SOPs, policies and practices.

**RESpONSIBILITIES** May act as a Project Manager for a large and complex stand-alone project or programme, involving several regulatory or technical deliverables and/or region, and/or operations. Undertakes risk analysis, management and contingency plans. Must ensure that regulatory colleagues on the project have the tools and training needed to undertake the various tasks.

• Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate to produce consistent results.

• Ensures compliance of regulatory processes and prepares for full Regulatory Affairs Systems Audits, accountable for any subsequent action plans.

• Competently manages meetings/expectations with Regulatory Agencies and/or groups within Quintiles.

• May take leadership role in bid defense strategy and planning.

• May act as global regulatory or technical representative in major cross-functional global initiatives and/or may lead a global regulatory/technical initiative.

• May lead/chair a session on Regulatory Affairs or related topics at a conference; deliver effective presentations to a broad audience.

**Qualifications:**

**REQUIRED KNOWLEDGE, SKILLS AND ABILITIES**

Must have extensive experience in writing regulatory &/or technical documents.

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

Possesses an acute awareness of issues outwith the business function. Exudes confidence and authority within remit, delivering a positive example to project teams

Remains motivated and enthusiastic in times of change and other pressure situations

Demonstrated ability to seek and apply industry trends within functional areas of expertise; conscientious of marketing opportunities

**MINIMUM REQUIRED EDUCATION AND EXPERIENCE** Degree in life science-related discipline or professional equivalent plus at least 10 years relevant experience* including 8 years regulatory experience (*or combination of education, training and experience)

EEO Minorities/Females/Protected Veterans/Disabled

**Primary Location:**

USA-Maryland