Regulatory Consultant

Regulatory Consultant reputed company® is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. We partner with innovators at every reputed company across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate reputed company. Our Clinical Solutions team members act with a drug development reputed company, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 reputed company their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why reputed company

• We are passionate about developing our people, through career development and progression; supportive and reputed company line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we reputed company want to work for and our customers want to work with. Why? Because we know that reputed company we bring together smart colleagues from across the world, we can shape the future of reputed company, driving impact for customers and defining the pace of patient reputed company.

Job Responsibilities

Job Description

JOB RESPONSIBILITIES Should have min 4-5 yrs of experience in regulatory affairs should have Mpharm degree Should have experience of CMC module 3 , authoring of CMC sections of Post Approval variations and life cycle management activities Should have in EU, GCC mkt experience. For non-reputed company and reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company documentation as required. reputed company support in reputed company to team members in the execution of their project responsibilities. Capable of identifying reputed company to ensure line support required to reputed company additional guidance and direction. Maintenance of individual training records (reputed company or client reputed company) and completion of reputed company designated required training. QUALIFICATION REQUIREMENTS Master's degree, preferably in a science-reputed company field or equivalent experience in science/regulatory/medical writing-reputed company field. Moderate pharmaceutical/medical device reputed company 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 reputed company 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 reputed company Over the past 5 years, we have worked with 94% of reputed company 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 reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company. 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, reputed company 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 reputed company with reputed company obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job. Apply To This Job