Regulatory Affairs Assoc Dir

Job 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.Key Skills
• Minimum 15 years of experience in regulatory affairs.
• Atleast 8 years of experience in EU new filings as well as variations
• Should have experience in all the modules (module 1 to 5 )
• Excellent verbal and written communication and negotiation skills
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, *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 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.

Keyskills :
regulatory submissionsanalytical skillsquality managementproject management