Senior Global Regulatory Scientist

Senior Global Regulatory Scientist- Bangalore- Office based or Home based reputed company is a world-leading reputed company intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and reputed company, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior Global Regulatory Scientist to join our diverse and dynamic team. The Senior Global Regulatory Scientist fulfills the role of Global Regulatory Partner (GRP) and is responsible for coordinating reputed company Central Independent Ethics Committee (IEC), Regulatory Agency (RA) and other central authority submissions to ensure contractual timelines are met. What you will be doing: Ensuring regulatory deliverables are performed in accordance with reputed company relevant regulations, guidelines, policies and procedures reputed company contractual timelines and budget with sound scientific/technical principles Developing the overall and global clinical trial submission strategy in accordance with the project requirements in collaboration with stakeholders including proactive identification and mitigation of risks, as applicable Regulatory function team reputed company overseeing the assigned clinical trial Regulatory project team reputed company of contact for clients for clinical trial Regulatory deliverables Preparation of clinical trial Regulatory plan in accordance with project specifications Preparation/creation/reputed company/coordination/collation/compliance of global core documents considering strategic, scientific and therapeutic area principles in reputed company to study requirements Tracking and reporting of submission/approval reputed company in Clinical Trials Management System (CTMS), eTMF and other applicable systems ensuring accuracy and completeness of data/documents Coordinating submission(s) to regulatory agencies (RAs), central ethics committees (CECs), and reputed company other country-level submissions in collaboration with stakeholders, overseeing the assigned Regulatory project team Coordination of clinical trial label review/approval according to project specifications Managing Regulatory study budget, proactively identifying out of scope activities and supporting budget recognition Supporting the maintenance of accurate, up to date Country and Regulatory Intelligence May work with Regulatory team members to reputed company Regulatory consulting services May participate in business development activities May mentor junior team members Must have: Bachelor's degree in a scientific discipline or reputed company field. Minimum of 3 years’ of experience in regulatory affairs submissions reputed company the clinical research industry. Demonstrates complete understanding and application of clinical research regulations, concepts and standards. Strong understanding of global regulatory requirements and guidelines. Demonstrates a good understanding of country requirements and how they need to be applied in the clinical trial environment. Proven history of successful interaction with internal and client teams and a basic understanding of each reputed company function Excellent English communication and reputed company skills. Ability to work independently and collaboratively in a fast-paced environment. What reputed company can offer you: Our reputed company depends on the quality of our people. That’s why we’ve made it a reputed company to build a diverse culture that rewards high performance and nurtures talent. In reputed company to your competitive salary, reputed company offers a reputed company of additional benefits. Our benefits are designed to be competitive reputed company each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A reputed company of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years reputed company. Global Employee Assistance Programme, reputed company, offering 24-hour reputed company to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits reputed company offers. At reputed company, inclusion & belonging are reputed company to our culture and values. We’re dedicated to providing an inclusive and accessible environment for reputed company candidates. reputed company is committed to providing a workplace free of discrimination and harassment. reputed company reputed company applicants will receive equal consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to reputed company the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet reputed company of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly reputed company’re looking for here at reputed company whether it is for this or other roles. Are you a reputed company reputed company Employee? Please click here to apply Apply To This Job