Associate Director Regulatory Affairs client dedicated

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Associate Director, Regulatory Affairs (client dedicated) The Associate Director, Regulatory Affairs will be fully dedicated to a specific sponsor as part of the FSP (Functional Service Provider) function within **MEMBERS ONLY**SIGN UP NOW***.. Every partnership is unique with each one tailored to achieve our customer's visions and goals. Sponsors expect our colleagues to be an extension of their team and to bring new ideas; demonstrate expertise in technology and processes; escalate recommendations for improvements and take opportunities to innovate. This is an excellent opportunity to work with a sponsor who is passionate in developing genomic medicines to transform the lives of patients with serious diseases. In this role you would work with cutting-edge technology platforms within gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. Come discover what our 25,000 employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the **MEMBERS ONLY**SIGN UP NOW***. team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why **MEMBERS ONLY**SIGN UP NOW***. nn #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. n We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental, and financial. n We are continuously building the company we all want to work for and our customers want to work with. n Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. nn Job responsibilities: This Regulatory position will be responsible for managing regulatory affairs activities for a single a fully dedicated client's clinical development programs from preclinical candidate designation through drug approval, including regulatory submissions, such as IND/CTA/GMO/BLA/MAA, amendments/annual reports, and relevant quality documents. Responsibilities include timely planning and coordinating of regulatory submissions, providing support to cross-functional teams on regulatory strategy, working with project teams, assisting on authoring and managing regulatory submissions, archiving and submission tracking. Continued responsibilities for maintaining an in-depth awareness of relevant FDA and EU regulations and policies to optimize regulatory input to assigned projects and teams. A minimum of five years of these Regulatory activities and responsibilities required. nn May oversee people management activities including interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee n counseling. n Ability to mentor and coach managers and supports team managers on all administrative or departmental activities. n Facilitate processes, resourcing, and communications within a department, across departments, or within the country assigned. n Acts as liaison and facilitator between customer leaders and senior management for related tasks and/or issues. n Plans and negotiates resources with line management of functional areas. n Serves as a departmental point of escalation for internal and external customers. n May be responsible & accountable for the effective operations and SSU project deliverables across all regions, within the assigned programs/projects. n May develop and maintain strategic relationships with customers. n Collaborates with business leads for business development, alliance management, contracts and proposals development, project management, clinical management, operational personnel, and executive management to achieve project goals. n Ensures that individual project targets are met, clients are satisfied, services are provided with the highest quality standards and policies and procedures are followed. n May support management with site start-up and financial management tasks of projects, as well as strategy development for process improvement. Facilitates and supports project reviews with Clinical Operations staff, focusing on budget, schedule, and risk analysis. Supports reporting of department and team metrics/cycle times and strategies to improve metrics/cycle times n Guarantees SSU delivery of assigned projects and/or initiatives. n Involved in reviewing, approving, and presenting prepared information at project or departmental review meetings. Develops and implements training programs for appropriate departmental teams. n Interacts with internal or external Legal Departments and assists with the accurate creation and implementation of contract management workflows or with the contract management group. n Identifies and reports on areas of process and contract risk. n Oversees the implementation of customer-required and/or enterprise-wide project management systems and tools. Participates in the development, implementation, and maintenance of enterprise project management systems, acting as a systems manager; may supervise a systems administrator. n Develops requirements for modifications to existing systems, metrics and reports based on input from functional teams. Provides input and requirements for long-range IT plans. n Implements Company and/or customer-required project management systems and processes. n Leads larger teams of subject matter experts in the development and review of Standard Operating Procedures (SOPs) and Work Instructions (WI) to support new or existing processes. n Develops and implements strategies and tools for tracking contract management team metrics/cycle times. n Responsible for creating a predictable project experience for both employees and clients alike. n Contributes to and may lead change initiatives across the SSU and Regulatory department. n Develops and implements strategies and tools for tracking metrics/cycle times. n Oversees all quality control efforts of individual departmental teams. n Represents the Company at professional meetings or seminars. n Establishes and maintains training materials for assigned area. nnQualifications: What we're looking for: nn Bachelor's Degree n Experience in managing teams of clinical research employees n Strong leadership skills; ability to teach/mentor team members n Ability to coach employees to reach performance objectives n Ability to recognize and take appropriate action when employee performance is not acceptable n Extensive Clinical Trial experience n Strong knowledge of clinical research management processes. n Understanding of the needs of countries and the ability to work across geographic regions. n Strong CRO operational experience with a track record in project management working in an international or global capacity. n Thorough knowledge of applicable regulations, drug development, and clinical project management procedures. n Strong presentation, documentation, and interpersonal skills. n Proficient in MS Office (Word, Excel, and PowerPoint), MS Project, email, and Internet. n Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment. nn Get to know **MEMBERS ONLY**SIGN UP NOW***. We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about **MEMBERS ONLY**SIGN UP NOW***.. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated #LI-HCn}

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