Job title: Regulatory Consultant(CMC)
Company: inVentiv Health Clinical SRE, LLC
Job description: Job Description : Regulatory Consultant 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 e
Job Description : Regulatory Consultant 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. Skills required : Minimum 5 years of experience in writing Module 3 (CMC) Exposure in US, Australia, EU, Canada, Japan,China, Brazil market (CMC authoring) Sound knowledge of ICH guidelines and submission requirements of various markets such as USFDA, EMA etc. Ability to motivate fellow team members, provide troubleshooting, tracking deadlines and potential to act as a first- or second-degree reviewer Excellent Communication skills Effective management of individual workload Analytical capabilities, familiarity and comfort with regulatory concepts Professional service mentality. Knowledge/experience on review and mapping of technical docuemnts like COA’s, specifications, Analytical/process validation reports, development reports, stability reports and protocol to respective CTD sections. Should have good understanding or ability to search existing and new CMC guidelines for any region. Advance level knowledge on steps undertaken from CMC perspective for any CMC sections gap assessments for any baseline or site transfer activities. Job responsibilities For non-complex and complex submissions, independently fulfill the following responsibilities: Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions. Contribute to or prepare administrative and technical components of regulatory agency submissions for the IND, for pre-approval submission packages, for product registration applications, and for post-approval maintenance. Prepare briefing packages for regulatory agency meetings or scientific advice and contribute to or support the agency interactions. Manage and/or operationalize the delivery of day-today regulatory activities for assigned project according to agreed timelines, scope of contract, budgets, and strategies. Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle. Act as a subject matter expert and help the team members with day-to-day trouble shooting activities, presenting solutions to project related problems. Prepare estimates for conducting regulatory services as part of single or multiple service proposals. Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities. Ensure compliance with appropriate global regulatory requirements and the company’s policies and processes. Prepare training materials and share best practices in the regulatory area, both internally and externally. Participate as regulatory support in internal or external project audits. Participate as regulatory support on internal cross-functional initiatives. Contribute to the creation and/or maintenance of SOPs and other process related documentation as required. Provide support in oversight to team members in the execution of their project responsibilities. Capable of identifying when to ensure line support required to provide additional guidance and direction. Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training. Qualifications What we’re looking for BS or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. Moderate pharmaceutical/medical device related experience. 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 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.
Job date: Wed, 16 Feb 2022 23:47:08 GMT
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