Medpace—Regulatory Submissions Coordinator (Senior/ Experienced)

Job description

Description: We are currently seeking a full-time, office-based* Experienced/ Senior Regulatory Submissions Coordinator to join our Clinical Operations team in India, Mumbai. Our culture is of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our business partners. At Medpace, our employees embody our values and our approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons why talented individuals join the Medpace team. *Office based with hybrid work arrangements based on eligibility Responsibilities - Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials; - Prepare, review, and submit to Regulatory Agencies; - Communicate with global study teams and personnel on study progress; - Ability to effectively identify risks to site activations and mitigate as necessary; - Provide expertise and guidance to global study teams in ethics and regulatory submissions; - Review and finalize essential documents required for site activation; - Act as a main contact for Ethical and Regulatory submission-related activities; - Direct contact with investigative sites during the study start up and activation process; - Ensure submissions comply with applicable regulations and guidance documents; - Advise sponsors on changing regulations and compliance requirements; and - Track submissions and ensure timely filing of documents. Qualifications - Bachelor’s degree in science field and more than 4 years of regulatory submissions experience in clinical research, preferably with a CRO. - Hands-on experience preparing, reviewing, and submitting regulatory documentation to ECs and RA (minimum CDSCO and DCGI); including formulating responses to queries. - Open to travel to Delhi as needed will be a plus point. - Strong oral and written communication skills. - Position comensurate with experience. Strong Local experience mandatory for Regulatory Submissions Coordinator level, Local and Regional APAC experience mandatory for a Regulatory Submissions Manager level Medpace Overview Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries. Why Medpace? When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration. Purpose-Driven Work - - Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence Collaborative Culture - - Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust. - Leadership throughout Medpace is both accessible and approachable Continuous Growth & Development - - Office based environment with on-site mentors - Defined career paths with clear advancement opportunities - Industry renowned onboarding and training programs designed to accelerate professional development - Ongoing training and continuous learning opportunities throughout your career - An environment that encourages employees to influence change, contribute ideas, and grow quickly Other Employee Benefits - - Competitive compensation programs that recognize and reward performance - Comprehensive health, wellness, retirement, and PTO benefits - Office based culture with occasional WFH that provides flexibility for eligible positions after training - Company-sponsored social events Please note benefits may vary based on country. What to Expect Next A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted. Responsibilities: - Perform required activities within the country that lead to activation of investigative sites in all phases of clinical trials; - Prepare, review, and submit to Regulatory Agencies; - Communicate with global study teams and personnel on study progress; - Ability to effectively identify risks to site activations and mitigate as necessary; - Provide expertise and guidance to global study teams in ethics and regulatory submissions; - Review and finalize essential documents required for site activation; - Act as a main contact for Ethical and Regulatory submission-related activities; - Direct contact with investigative sites during the study start up and activation process; - Ensure submissions comply with applicable regulations and guidance documents; - Advise sponsors on changing regulations and compliance requirements; and - Track submissions and ensure timely filing of documents.