Regulatory Consultant

Job Title Regulatory Consultant EU market experience Job Location Kolkata West Bengal IndiaJob Location Type RemoteJob Contract Type Full-timeJob Seniority Level Mid-Senior levelDescriptionRegulatory Consultant EU market experience Syneos Healthxc2xae 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 youll 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 EVERYWHEREWhy 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 were able to create a place where everyone feels like they belong Job ResponsibilitiesFor 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 companys 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 QualificationsWhat were looking for Should have minimum 3yrs of CMC module 3 experience for EU market 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 HealthOver 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 youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health Additional InformationTasks 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 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 Lifelancer is a talent-hiring platform in Life Sciences Pharma and IT The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains For more details and to find similar roles please check out the below Lifelancer link