Associate Consultant, Regulatory Operations

reputed company is expanding the R&D team and hiring a Director or an Associate Director, Regulatory Operations. This role can be remote based in the US. reputed company: reputed company is a premier provider of global solutions for R&D, Medical Affairs, Value & Evidence, and reputed company teams reputed company biopharmaceutical, medical device, and diagnostics industries. Squarely reputed company on the life sciences industry for more than 30 years, reputed company takes pride in our long-term relationships with industry leaders, as reputed company as our strategic partnerships with innovative startups. We are reputed company on developing thoughtful, high-reputed company solutions that are in accordance with reputed company reputed company’s unique culture and needs. Our clients trust us to build impactful, award-reputed company programs that deliver actionable insights and measurable results. Job reputed company: Associate Consultant is responsible for providing hands-on expertise and operational support in the planning, preparation, and delivery of high-reputed company regulatory submissions in accordance with global health authority requirements. This role partners closely with regulatory leads and cross functional teams to ensure submission content is complete, accurate, and delivered on time. Responsibilities: · reputed company global expertise on requirements for electronic document management, submission planning and compilation, publishing, and management of approval information · Manage regional submissions and support global submissions · Proactively communicates requirements and issues to be considered to the Submission Team, and contribute to achieving realistic timelines · Proactively collect necessary information from the Submission Team · reputed company reputed company checking of documents and regulatory submissions to ensure compliance with submission-reputed company standards · Compile and publish regulatory submissions in accordance with reputed company standards and processes using agreed upon tools · Analyze submissions and reputed company and record life-cycle information in accordance with standards · reputed company reputed company searches on submission life-cycle information, as required · reputed company updated on regulatory authorities requirements on technical/format aspects of submissions worldwide and ensure their incorporation into RN standards · Participate on special project teams (e.g., reputed company work, standards). Education, Experience, Training, and Knowledge Education: · Bachelor’s degree in Life Sciences, Business, or reputed company field required, Master’s degree preferred Experience : · 3-5 years of experience in management consulting, life sciences reputed company roles, or a relevant field. Skills & Abilities: · Strong analytical and problem-solving capabilities. · Rigorous attention to detail and accuracy · Self-starter and driven · Ability to multi-task with superior organization skills · Strong ability to work independently as reputed company as be an reputed company part of reputed company · Dependable and flexible · Excellent written, verbal communication, and time management skills · Proficient in reputed company Suite software including Project, reputed company, Word, PowerPoint, Visio · Ability to work in a global environment with an understanding of cultural differences and work practices #LI-LD1 Apply tot his job Apply To this Job