![]() ![]() With a single vision as inspiring as Transforming patients’ lives through science™, every BMS employee plays an integral role in work that goes far beyond ordinary.Įach of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. ![]() Uniquely Interesting Work, Life-changing Careers Required Knowledge : Up-to-date regulatory knowledge required to do the job as described above, and experience with new drug development work.Įxcellent communication skill & fluency in English, good presentation skills, excellent strategic thinking ability, good negotiation skills, excellent leadership skills, excellent problem-solving ability, excellent coaching skills, and good facilitation skills. Professional experience with 5-10 years of relevant regulatory experience Required degrees, certifications, and / or licensure relevant to role- Bachelor’s degree or master’s degree in science equivalent or B Pharm or M Pharm Support the GRS lead in mentoring and continuous development of the team.Can deputize the GRS lead in external and internal shareholder engagement as required.Collaborate with key partners with the country Business function, medical function, Clinical Operations function, Market Access function and Logistics function.Creates and updates local procedural documents.Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases.Responsible to keep up to date with the regulatory environment within the industry.Responsible for identification of opportunities to improve departmental functions / processes.Drives and support local projects and department related assignments.Responsible for interactions with Country Regulatory Authorities and feedback to BMS regarding product registrations.Responsible for filing clinical trial applications to the competent regulatory authorities in country, and all following interactions, in line with BMS company policies and practices where applicable.Responsible for assuring that approved labelling (PIL, PI, pack) is implemented in production in accordance with local legislation.Ensure the local labeling requirement are developed in alignment with local regulatory requirement and BMS standards.Responsible for complying the regulatory processes in line with business / R&D objectives to ensure timely registration of new products / line extensions and variation applications of BMS products.To manage and execute coordination, compilation and review all marketing and import registration applications and Clinical Trial application and maintenance application. ![]()
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