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Regulatory Affairs Manager

2 months ago

Hong Kong, Central and Western District, Hong Kong SAR China Bristol Myers Squibb Full time

Join Our Team
At Bristol Myers Squibb, we believe in the power of meaningful work. Our environment is anything but ordinary, where every day presents unique challenges and opportunities across various departments. From enhancing production processes to pioneering advancements in cell therapy, our work has a profound impact on patients' lives and the careers of our dedicated employees. Here, you will have the opportunity to grow and excel in a diverse and high-achieving team.

Key Responsibilities:

· Independently manage regulatory submissions, including new product registrations, variations, renewals, and clinical trial submissions to health authorities.

· Collaborate with global teams and other departments to develop effective regulatory strategies.

· Ensure adherence to internal standards and external regulatory agency requirements.

· Stay informed about regulatory and industry developments, seeking opportunities to enhance the efficiency of submissions.

· Provide regulatory guidance and support to various functions to meet both regulatory and business objectives.

· Maintain accurate statutory records, registers, databases, and routine documentation.

A Culture of Innovation and Inclusion
At BMS, we are united by a common vision: "Transforming patients' lives through scienceTM." Every employee plays a crucial role in our mission, empowered to leverage their unique talents and perspectives within an inclusive culture. We prioritize diversity in clinical trials and uphold shared values of passion, innovation, urgency, accountability, inclusion, and integrity, fostering the highest potential in all our colleagues.

Work Environment

BMS offers a flexible work structure that defines where employees conduct their work. This includes roles that are site-essential, site-by-design, field-based, and remote-by-design. The type of occupancy assigned is based on the responsibilities of the position:

- Site-essential roles require full onsite presence at the designated facility.

- Site-by-design roles may offer a hybrid work model, necessitating at least 50% onsite presence.

- Field-based and remote-by-design roles require the ability to travel for meetings and visits as needed.

BMS is committed to ensuring that individuals with disabilities can thrive through a transparent recruitment process, reasonable workplace accommodations, and ongoing support in their roles. If you require assistance during the application process, please inquire about reasonable accommodations.

BMS prioritizes the health and safety of our employees, customers, patients, and communities. Therefore, we strongly recommend that all employees are fully vaccinated against Covid-19 and stay updated with boosters.

BMS is an equal opportunity employer and will consider qualified applicants with arrest and conviction records in accordance with applicable laws.

All data processed in connection with job applications will be handled in compliance with relevant data privacy policies and regulations.