Director, R&D Regulatory Strategy

Director, R&D Regulatory Strategy

Location : NC-Clayton, US

Contract Type : Regular Full-Time

Area : R & D

Summary :

Leads the R&D Regulatory Strategy group for assigned products in managing regulatory programs in support of R&D activities. Oversees and / or participates in the development and implementation of worldwide regulatory programs for new product or new indication development, and leads interactions with regulatory authorities to expedite approvals. Coordinates department activities with related RA functions to assure efficient and consistent execution of department functions. Represents the department at senior-level, cross functional teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and adherence to regulatory requirements. Oversees staff to ensure the efficient operations of the function.

Primary Responsibilities :

• As Global Regulatory Lead, develops and oversees worldwide regulatory strategies for projects and issues affecting new products or new indication development.
• Leads interactions and negotiates with global regulatory authorities regarding programs and initiatives that significantly impact the business.
• Serves as a resource to other departments inside and outside of R&D on regulatory-related product development issues.
• Guides, directs, and leads staff, and develops department goals in accordance with business priorities. Responsible for training, reviews and development of department members.
• Advises Senior Management on regulatory aspects of product development and / or lifecycle management. Identifies business implications of complex regulatory and clinical issues, develops risk mitigation strategies and communicates in a manner that facilitates decision making.
• Serves as Grifols regulatory liaison in collaborative projects with other companies
• Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging / changing regulatory requirements.
• Manages department resources and budget to meet R&D goals
• Utilizes scientific training when interfacing with Senior Management of technical areas to guide the scope of experimentation and the selection of data needed to support regulatory submissions

Knowledge, Skills, & Abilities :

Comprehensive knowledge and understanding of FDA and global regulatory requirements for the biotechnology and pharmaceutical industry. Deep experience in clinical development, trial design statistical principles is essential. Excellent oral and written communication skills. Strong critical thinking and problem solving skills. Excellent and demonstrated project management skills. Ability to negotiate and influence regulatory officials. Ability to work cross-functionally to effectively implement and oversee R&D regulatory programs. Ability to evaluate complex issues, develop a plan, and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Ability to work within a global team framework and multi-cultural environment.

Minimum Requirements :

Requires Ph.D., Pharm. D.,M.D. or equivalent and, 8 years direct experience in Medical Research, Clinical, Regulatory Affairs or other critical areas within the pharmaceutical industry.

Occupational Demands :

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations and frequently travels within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.