Regulatory Affairs Operations Specialist
22 hours ago
We are seeking an experienced Regulatory Affairs Operations Specialist to join our team. This role will play a key part in supporting the growth and development of biotech startups through regulatory affairs and operational management.
About the Role
The ideal candidate will possess a strong understanding of regulatory frameworks in the life sciences industry, with experience in program management, stakeholder coordination, and regulatory affairs support.
Main Responsibilities
- Program Management: Provide operational support and account management for biotech programs, ensuring smooth development and execution.
- Stakeholder Coordination: Facilitate connections for start-up companies with relevant service providers, including Contract Research Organizations (CROs), regulatory authorities, and quality system developers, to meet clinical trial and regulatory requirements.
- Regulatory Affairs Support: Coordinate the application process for regulatory funding and assist companies with regulatory submissions, ensuring all processes comply with internal and external guidelines.
- Meeting Coordination: Serve as secretary for major program meetings, including panel assessments, milestone evaluations, and client meetings, ensuring internal controls are in place for compliance.
- Program Evaluation: Conduct evaluations of program applications, arranging due diligence and assessment meetings, and providing input for continuous program enhancements.
- Standard Operating Procedures (SOP) Updates: Contribute to the ongoing improvement of program SOPs and processes, supporting the continuous development of the ecosystem.
- Ad-hoc Duties: Perform other related duties as assigned by the management team.
Requirements
- A bachelor's degree in life sciences, biomedical sciences, biomedical engineering, or other related fields, or an equivalent qualification.
- At least 5 years of work experience, preferably in regulatory affairs or project management in the medical devices, pharmaceutical, or biopharma industries.
- Experience in CRO/CDMO management, protocol development, Investigational New Drug (IND) filing, and regulatory submissions (FDA, NMPA, etc.) is an advantage.
- Knowledge or experience in clinical trials and clinical affairs, particularly in medical devices and pharmaceuticals, is a plus.
- Strong interpersonal, communication, and presentation skills. A proactive, self-motivated, and results-oriented approach.
- Proficient in spoken and written English and Chinese, including Mandarin.
- Candidates with higher education or professional qualifications and less experience will also be considered.
What We Offer
- A dynamic and innovative work environment within a leading hub for technology and innovation.
- A 5-day work week with competitive annual leave and additional special leave.
- Comprehensive medical benefits, including dental and annual check-ups from day one, with extended coverage for dependents.
- Access to professional training and career development opportunities.
- Convenient transportation options, with a bus network connecting various locations across the city.
This is an exciting opportunity for an ambitious professional to contribute to the growth of biotech startups and make a significant impact in the life sciences sector.
-
Regulatory Affairs Specialist
4 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Crypto Connect Full timeJob Summary">We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Crypto Connect. In this role, you will be responsible for ensuring that all legal contracts and agreements are in compliance with applicable laws and regulations.About the Role">The Regulatory Affairs Specialist will assist with the organization and execution of...
-
Regulatory Affairs Specialist
22 hours ago
Hong Kong, Central and Western District, Hong Kong SAR China Hong Kong Exchanges and Clearing Limited Full timeCompany Overview:Hong Kong Exchanges and Clearing Limited is home to Asia's most dynamic and vibrant capital markets, connecting capital, ideas, inspiration, and innovation for deeper, more diverse, and liquid global capital markets.The company provides greater choice and opportunity for its customers every day. Its purpose is to Connect, Promote, and...
-
Communication and Public Affairs Specialist
22 hours ago
Hong Kong, Central and Western District, Hong Kong SAR China KN Group Full timeJob OverviewThe KN Group is seeking a highly skilled and experienced Communications and Public Affairs Specialist to join our team. This role is ideal for individuals who are passionate about public relations, communication, and community engagement.Key ResponsibilitiesAs a Communications and Public Affairs Specialist, you will be responsible for assisting...
-
Senior Regulatory Affairs Manager
5 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Recruitment Intelligence Consultants Limited Full timeJob Title: Team HeadWe are seeking a highly skilled and experienced professional to lead our client's regulatory and compliance initiatives, focusing on enhancing the bank's risk management framework.The ideal candidate will be responsible for managing projects that ensure compliance with legal and regulatory requirements, working closely with senior...
-
Hong Kong, Central and Western District, Hong Kong SAR China Capital Access Limited Full timeCapital Access Limited seeks an experienced legal and compliance professional to lead our daily operations. Reporting directly to the CEO, you will oversee a small team managing various business areas, ensuring the legality and compliance of our operations. You will develop and maintain external relationships with law firms, regulatory bodies, and government...
-
Hong Kong, Central and Western District, Hong Kong SAR China Fortune&Future Hong Kong Limited Full time**Company Overview:**Fortune&Future Hong Kong Limited is a leading organization that specializes in financial management services. Our company values expertise, professionalism, and attention to detail.**Job Description:**We are seeking an experienced Financial Operations Specialist to join our team. The ideal candidate will have extensive knowledge of...
-
Financial Operations Specialist
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Bank Of China (Hong Kong) Limited Full timeAbout UsThe Bank Of China (Hong Kong) Limited is a leading financial institution in Hong Kong, committed to providing exceptional banking services to our customers. We are seeking a highly skilled and experienced professional to join our team as a Financial Operations Specialist.Responsibilities:We are responsible for ensuring the smooth operation of our...
-
Hong Kong, Central and Western District, Hong Kong SAR China KPMG Full timeKPMG China provides multidisciplinary services from audit and tax to advisory, with a strong focus on serving our clients' needs and their industries. At KPMG, you will work in an environment where we strive to become a responsible corporate citizen that has a positive impact on our environment and community.Service Line OverviewKPMG Managed Services...
-
Regulatory Affairs Professional
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Hong Kong University Full timeCompany OverviewThe Hong Kong University, a leading institution in the field of medicine and life sciences, is seeking a highly qualified candidate to fill the position of Vice President (Research Strategy Development & Application). The successful applicant will be responsible for driving the development and implementation of strategies related to clinical...
-
Investment Operations Specialist
6 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Omni Group Asia Ltd. Full time**Job Overview at Omni Group Asia Ltd.**We are seeking an experienced Investment Operations Specialist to join our team in ensuring the efficient execution of investment operations.The ideal candidate will possess a strong background in fund or investment operations, with excellent analytical and problem-solving skills.**Key Responsibilities:**Maintain...
-
Hong Kong, Central and Western District, Hong Kong SAR China Futu Securities International (Hong Kong) Limited Full timeFutu Securities International (Hong Kong) Limited is seeking a highly skilled Senior Legal Specialist to join our team in Hong Kong. The successful candidate will be responsible for providing comprehensive legal support across the Group's international operations.Key Responsibilities:Legal Support: Provide expert legal advice and guidance on commercial,...
-
Financial Operations Specialist
22 hours ago
Hong Kong, Central and Western District, Hong Kong SAR China One Arrow Consulting Full timeOne Arrow Consulting OverviewWe are seeking a highly skilled and detail-oriented Financial Operations Specialist to join our team. In this role, you will be responsible for executing trade verification, affirmation, and processing for various financial products, including FX, cash equities, OTC swaps, bonds, interest rate derivatives, and equity...
-
Financial Services Specialist
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Fortune&Future Hong Kong Limited Full timeCompany OverviewFortune&Future Hong Kong Limited is a reputable firm specializing in financial services for charitable trusts, Cayman Islands funds, foundations, and Hong Kong licensed companies.Job SummaryWe are seeking an experienced Financial Services Specialist to join our team. The successful candidate will be responsible for handling various financial...
-
Senior Treasury Operations Specialist
7 days ago
Hong Kong, Central and Western District, Hong Kong SAR China ALL-STAR AGENCY Full timeALL-STAR AGENCY is seeking a highly motivated and detail-oriented Senior Treasury Operations Specialist to oversee the smooth execution of treasury-related activities.This role involves supervising the team's daily activities, ensuring all transactions comply with Anti-Money Laundering (AML) and Counter-Terrorist Financing (CFT) measures and regulatory...
-
Market Operations Specialist
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China AXA Investment Managers Full timeAbout the RoleWe are seeking a highly skilled Market Operations Specialist to join our team at AXA Investment Managers.Company OverviewThe AXA Group is a global leader in insurance and asset management, with 160,000 employees serving 105 million customers in 62 countries. Our mission is to act for human progress by protecting what matters. We protect and...
-
Financial Services Operations Specialist
4 days ago
Hong Kong, Central and Western District, Hong Kong SAR China AIA International Limited. Full timeAbout AIA International LimitedAIA International Limited is at the forefront of creating a healthier, more sustainable future for everyone. Our mission is to nurture our financial wellbeing as an organisation, so we can better support and make a difference for our customers when they need us most.We're committed to ensuring our products are well-designed and...
-
Hong Kong, Central and Western District, Hong Kong SAR China Fargo Wealth Group Limited Full timeCompany OverviewFargo Wealth Group Limited is a leading financial institution with multiple offices across the globe, including Hong Kong, Mainland China, and Singapore. We are committed to providing top-notch IT services to support our business operations.Job DescriptionWe are seeking an experienced IT Specialist to join our team as an IT Operations...
-
Financial Operations Specialist
1 week ago
Hong Kong, Central and Western District, Hong Kong SAR China EG Asset Limited Full timeAbout EG Asset LimitedEG Asset Limited is a reputable financial services company that offers a range of investment solutions to its clients.We are currently seeking an experienced Financial Operations Specialist to join our team. The successful candidate will be responsible for managing the day-to-day financial operations of the company, including data...
-
Financial Services Professional
22 hours ago
Hong Kong, Central and Western District, Hong Kong SAR China Dah Sing Financial Group Full timeAbout Dah Sing Financial GroupThe Dah Sing Financial Group is a leading financial services organization in Hong Kong, offering a range of banking and insurance services through its extensive network. We prioritize a culture that values caring, teamwork, and progressiveness, recognizing the unique talents and growth potential of every individual.Our mission...
-
Accounting Operations Specialist
3 days ago
Hong Kong, Central and Western District, Hong Kong SAR China Alter Domus Full timeWe are committed to delivering exceptional services to our clients.As a member of our team, you will be responsible for providing support with the administration and accounting of a portfolio of clients.Your key responsibilities will include:Ensuring the day-to-day operations of the funds are run smoothly and efficiently;Coordinating with third parties,...
