Description Regulatory Associate ( CMC) Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 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 Primary Understands current global regulatory guidelines (ICH, FDA, EMA, etc.) for post approval changes. Preparation of high-quality global CMC dossiers for variations, renewals, annual reports and other lifecycle maintenance activities including change control assessment, Response to Queries /follow up queries, according to current Health Agencies’ regulations and guidelines Ability to interpret client processes and SOPs for day-to-day execution tasks Supports in preparation, review and finalization of quality compliance reports (APQR – Annual product quality review) Supports in building ancillary or document request trackers. Liaise with different functions to arrange required documentation for global submissions Timely sensitization /escalation within team to maintain compliance and adherence to timelines. Secondary Understands Regulatory (of different regions like LATAM, APAC, ME, AF, China etc) requirements for Marketing Authorization dossier applications for ROW markets. Supports in tracking and submission of regulatory/CMC commitments and update the databases Experience of RIMS/VEEVA vault will be preferred. Open to working in Cross-Cultural/Virtual teams Good communication skills - clearly articulate through emails/ calls; provide accurate update on regulatory activities for assigned products in internal or Client meetings Good aptitude and attitude to learn Qualifications Minimum 1 years of experience required for preparation of high-quality global CMC dossiers for variations, renewals, annual reports and other lifecycle maintenance activities including change control assessment . Master’s degree in pharmaceutical sciences (preferred) or master’s degree in other life sciences. Post approval variation experience is mandatory for EU MARKET And Pre-approval MAA Dossier Experience (for ROW) Is Preferred. Demonstrated experience in contributing to the preparation of regulatory submissions including, for example IND, PMA, NDA, MAA, and CTD, including electronic submissions. 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 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. Fluent in speaking, writing, and reading English. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com 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. Summary Under supervision, supports regulatory agency submissions, regulatory research, and product development. Responsibilities typically include working closely with RA team members, creation of submission documents to support the preparation, tracking, and submission of regulatory documentation across various global marketsfor new submissions, variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities. Also, exposure to tools like Veeva RIM or other regulatory systems. Show more Show less
