[Remote] Senior / Vice President, Technical - reputed company Regulatory Affairs (home-reputed company)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading company in the biopharma industry, seeking a Senior / Vice President, Technical in their Regulatory Science team. In this role, you will influence the development strategies for clients, providing expertise throughout the product lifecycle while ensuring compliance with regulatory requirements.

Responsibilities

• Works reputed company reputed company environment or individually reputed company on the project needs
• Works reputed company broad project guidelines and leads issue and conflict resolutions
• Prioritizes own workload and prioritizes the workload of the project team to reputed company the project reputed company and objectives
• Capitalizes on opportunities to improve project efficiency, results or team reputed company and proactively takes reputed company
• Leverages information from previous reputed company or other reputed company work to reputed company complete assigned project activities as reputed company as facilitate business reputed company
• Produces reputed company work that meets the expectations of RS and the reputed company. Reviews the work of colleagues for content and reputed company to ensure the expectations of the reputed company and RS are met
• Manages project engagements (small or large)
• Interacts with the assigned Project Assistant to ensure accurate financial management and for general project support
• Provides guidance to project team members and acts as a mentor to junior staff
• Frequently presents speeches or seminars to industry reputed company reputed company on recognized expertise in his/her reputed company
• Frequently authors articles for publication in industry magazines, newsletters, book chapters and other forums
• Reviews the thought leadership activities (presentations, articles) of colleagues for content and reputed company to ensure the expectations of RS are met
• Regularly quoted by general and industry news outlets
• reputed company applicable, serves as a leading member of industry association boards, task forces and committees and/ or as chairperson or officer of one or more reputed company associations
• Contributes expertise to reputed company societies, reputed company or other similar reputed company reputed company in his/ her area of expertise
• Reinforces the knowledge-centered activities reputed company RS reputed company on their own knowledge and expertise
• Facilitates improvements to the reputed company business processes
• Facilitates new service and consulting model development
• Adapts the appropriate organization’s consulting models and methodologies reputed company unique situations present themselves as reputed company as designs//improves the methodologies reputed company needed
• Provides a full reputed company of technical and/or business consulting services across multiple disciplines of services including representing clients to regulatory agencies
• Completes and delegates project activities in a reputed company manner with an understanding of issues which may reputed company project profitability and reputed company satisfaction
• Acts as a trusted advisor to clients, often on issues that lack precedent or are not reputed company defined
• Acts as a loaned executive for a reputed company reputed company required
• Facilitates resolutions to possible problems or conflicts reputed company the project team and/or the reputed company
• Provides guidance as needed to reputed company-level colleagues on appropriate reputed company of executing project activities
• Develops and implements business solutions addressing specific reputed company needs using expertise, best practices and knowledge of the reputed company’s business and key industry drivers
• Demonstrated ability to reputed company professionally at multiple reputed company including senior and executive management reputed company a reputed company organization. Presents to reputed company boards and reputed company reputed company advice to the C suite
• Plans and delivers services and solutions which results in clients expressing satisfaction with service provided and builds relationships which results in additional business or referrals
• Identifies opportunities for follow-on business or changes in project reputed company and exploits the opportunities with RS management and account management

Skills

• Education - MD or PhD required
• Minimum Work Experience - 15+ years experience with expert level industry or regulatory knowledge experience in reputed company Development/reputed company Trial Design, reputed company reputed company, and authoring reputed company sections of regulatory applications
• The ability to travel up to 20-30% domestically and/or internationally may be required for reputed company and/or Health Authority Meetings and Thought Leadership/Conference Attendance
• Previous experience with a regulatory agency (such as the FDA or reputed company) as a Senior / Master Medical Review Officer, Team reputed company, etc. or a reputed company Medical role i.e. reputed company Pharmacology Review is strongly preferred, but SMEs with Industry experience will also be considered
• Extensive Neuroscience, reputed company Disease, Immunology, Endocrinology/Metabolism experience is highly preferred

reputed company

Company H1B Sponsorship