Description Regulatory Affairs Associate Director 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 Syneos Health 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 Syneos Health - #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. - 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. - We are continuously building the company we all want to work for and our customers want to work with. 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. Job responsibilities - Contributes to planning for regulatory submissions in assigned region/country/project. - Responsible for day-to-day management of project teams and projects. - Acts as a representative of the regulatory department with other departments. - Supports business development, including generation of repeat business from existing clients and proposal development. - Develops, reviews, and monitors project budgets, reviews client invoicing. - Monitors personal utilization. - Acts as a key point of contact for clients and regulatory authorities. - Provides regulatory advice to Company associates. - Prepares consulting reports. - Provides strategic and operational advice to clients. - Arranges, leads, and reports on client and regulatory agency meetings. - Writes IND and product registration dossiers, clinical reports, and other regulatory documents. Manages project teams and preparation of regulatory submissions for conduct of INDs, product registrations, and post approval maintenance activities. - Contributes to the development of policies, goals, objectives, plans, and procedures for functions under assigned span of control. - Acts as a resource for technical knowledge and provides thought leadership in the area of expertise. - Participates in quality improvement efforts to increase overall operational efficiency. - Contributes to the building of regulatory systems needed for GRAS. - Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry events such as seminars, association meetings, authoring articles for trade journals, and participation in industry association through memberships and on committees. - Develops solutions to complex problems. - Provides internal training in appropriate areas of expertise to other departments Qualifications What we’re looking for - BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field or moderate pharmaceutical/medical device related experience. Moderate experience in regulatory. - Demonstrated experience in contributing to the preparation of regulatory submissions including for example IND, PMA, NDA, MAA, and CTD, including electronic submissions. Experience in niche submissions such as ODD, PIP/PMP an advantage. - Comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development. - Excellent interpersonal / communication skills including excellent written and verbal communication skills. - Excellent customer service skills, with the ability to work both as a team member and independently. - Good quality management and budgeting skills. - Good project management, problem-solving, and decision-making skills. - Advanced skills in Microsoft Office Applications. - Ability to interact with staff from multiple departments and offices to establish project standards. - Good initiative, adaptability, and pro-activity. - Strong analytical skills, good attention to detail. - Ability to work concurrently on projects, each with specific instructions that may differ from project to project. Get to know Syneos Health 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 Syneos Health. Additional Information: Tasks, duties, and responsibilities as listed in this job descripti
Madrid Spain

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