Regulatory Affairs Manager
Found in: Talent SG 2A C2 - 3 weeks ago
Representing a leading force in the pharmaceutical industry, our client is dedicated to pioneering life-saving therapies. We are currently seeking a talented Regulatory Affairs Manager to join their team, where you'll play a pivotal role in leading regulatory efforts. This position requires a blend of technical expertise and strategic acumen to navigate approval submissions and oversee lifecycle management for groundbreaking pharmaceuticals.
MAIN RESPONSIBILITIES- Develop and implement regulatory strategies for assigned pharmaceutical products, ensuring alignment with global standards and regulations.
- Efficiently manage the lifecycle and submission pipelines, maintaining adherence to time constraints.
- Act as the primary liaison with regulatory authorities, addressing inquiries and managing communication on regulatory issues.
- Stay abreast of evolving regulatory requirements, guidelines, and trends to inform and adapt regulatory strategy.
- Collaborate with internal stakeholders to align regulatory strategies with business objectives.
- Contribute to the development of the company's long-term regulatory strategy, identifying emerging trends and proposing proactive solutions.
- Ensure compliance with ethical, legal, and regulatory standards.
- Play a key role in maintaining the regulatory database, ensuring timely updates of regulatory information.
- Develop plans for regulatory compliance and product labeling, providing guidance throughout the product introduction process.
- Keep informed about changes in regulatory requirements in relevant countries.
- Relevant Bachelor's Degree (Bachelor's Degree in Pharmacy is an added advantage).
- Minimum of 5-7 years in the pharmaceutical industry, with a focus on innovative pharmaceutical pipelines, particularly in oncology and rare diseases.
- Proven track record of regulatory successes in end-to-end new drug/generic applications.
Note: Candidates demonstrating aptitude, a strong desire to learn, and adaptability may be considered, even if they don't meet all the specified requirements.
ESSENTIAL QUALITIES- Strong analytical skills to assess complex regulatory requirements and develop effective compliance strategies.
- Excellent communication skills to collaborate with cross-functional teams and communicate regulatory updates at all organizational levels.
- Detail-oriented mindset to ensure accuracy and completeness in all regulatory documentation and submissions.
Apply with your latest CV, detailing your relevant key achievements in regulatory affairs. We look forward to a confidential discussion about your potential role in our distinguished company.
Principal Consultant: Cheong Yee Yin
Registration Number: R22108633
EA License Number: 17C8502
Tell employers what skills you have
Excellent Communication Skills
Pharmaceutical Industry
FDA
Regulatory Compliance
Analytical Skills
Pipelines
Regulatory Affairs
Oncology
ISO
Regulatory Strategy
Adaptability
Compliance
Medical Devices
Regulatory Requirements
Life Sciences
-
Regulatory Affairs Manager
Found in: Talent SG 2A C2 - 2 weeks ago
Singapore INTEGRITY PARTNERS PTE. LTD. Full timeRoles & ResponsibilitiesPosition: Regulatory Affairs ManagerPorftolio: Local Responsibilities; Pharmaceuticals THE COMPANYAt the forefront in the pharmaceutical industry, they dedicated to pioneering lifesaving therapies. Currently seeking a Regulatory Affairs Manager to lead regulatory efforts, combining technical prowess with strategic acumen. POSITION...
-
Regulatory Affairs Manager
1 week ago
Singapore Integrity Partners Pte. Ltd. Full timePosition: Regulatory Affairs ManagerPorftolio: Local Responsibilities Pharmaceuticals THE COMPANYAt the forefront in the pharmaceutical industry, they dedicated to pioneering lifesaving therapies. Currently seeking a Regulatory Affairs Manager to lead regulatory efforts, combining technical prowess with strategic acumen. POSITION OVERVIEWAs the Regulatory...
-
Regulatory Affairs Specialist
Found in: Talent SG 2A C2 - 2 days ago
Singapore ACCESS-2-HEALTHCARE Full timeRoles & ResponsibilitiesCompany DescriptionAccess-2-Healthcare is a global consulting company dedicated to helping small to medium sized medical technology organizations overcome various challenges and launch their products in the market. Founded in 2015, the company has local offices in 14 countries and is dedicated to getting the job done by providing...
-
Regulatory Affairs Specialist
1 day ago
Singapore Access-2-healthcare Full timeCompany DescriptionAccess-2-Healthcare is a global consulting company dedicated to helping small to medium sized medical technology organizations overcome various challenges and launch their products in the market. Founded in 2015, the company has local offices in 14 countries and is dedicated to getting the job done by providing expertise to doctors,...
-
VP, Regulatory Affairs
Found in: Talent SG 2A C2 - 2 weeks ago
Singapore RXILIENT MEDICAL PTE. LTD. Full timeRoles & ResponsibilitiesPosition: Vice President, Regulatory AffairsGeographical Focus: Southeast Asia and Taiwan, expanding to the MENA marketResponsibilities: Lead the oversight of regulatory projects from inception to completion within the assigned portfolio, ensuring deep understanding and application of regulatory strategies in the Asia Pacific and...
-
VP, Regulatory Affairs
2 weeks ago
Singapore Rxilient Medical Pte. Ltd. Full timePosition: Vice President, Regulatory AffairsGeographical Focus: Southeast Asia and Taiwan, expanding to the MENA marketResponsibilities:Lead the oversight of regulatory projects from inception to completion within the assigned portfolio, ensuring deep understanding and application of regulatory strategies in the Asia Pacific and future global markets.Craft...
-
Regulatory Affairs Manager HNC
Found in: beBee S SG - 4 weeks ago
Singapore dsm-firmenich Full timeJob title – Regulatory Affairs Manager HNC Location – Singapore Job model – Hybrid To ensure that dsm-firmenich products comply with the diverse and complex regulations in the region, the Regulatory Affairs Manager will advise / define the internal requirements for new products to ensure efficient market clearances and compliance...
-
Executive, Clinical and Regulatory Affairs
1 week ago
Singapore Advanced Ophthalmic Innovations Pte. Ltd. Full time. Responsible for activities related to the Company's regulatory management systems, including coordinating, training, developing, improving, and implementing existing and new regulatory pathways.. Prepares, submits, tracks, indexes and archives electronic submissions including information, amendments, annual reports, general correspondence, adverse event...
-
Regulatory Affairs Specialist
Found in: beBee jobs SG - 2 weeks ago
Singapore Danaher Full timeWondering what's within Beckman Coulter Diagnostics? Take a closer look.At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds,...
-
Regulatory Affairs Manager
Found in: Talent SG 2A C2 - 4 days ago
Singapore INTEGRITY PARTNERS PTE. LTD. Full timeRoles & ResponsibilitiesAs a Regulatory Affairs Manager, your primary responsibility will be to lead submission processes and streamline regulatory procedures to secure product approvals across the APAC/Asia/ASEAN markets. Moreover, you will be tasked with fostering collaboration and ensuring compliance with regional regulations.Role Overview Lead the...
-
Quality Assurance
Found in: beBee S SG - 3 weeks ago
Singapore VIVO SURGICAL PRIVATE Full timeAbout UsVivo Surgical is Southeast Asia’s pioneering surgical technology disruptor, engaged in developing innovative medical device solutions for better surgeries. An ISO 13485 certified company with international accreditations such as the US FDA and EU CE Mark, our products target the medical needs of the world through innovative applications of science...
-
Quality Assurance
Found in: beBee S SG - 3 weeks ago
Singapore VIVO SURGICAL PRIVATE Full timeAbout UsVivo Surgical is Southeast Asia’s pioneering surgical technology disruptor, engaged in developing innovative medical device solutions for better surgeries. An ISO 13485 certified company with international accreditations such as the US FDA and EU CE Mark, our products target the medical needs of the world through innovative applications of science...
-
Regulatory Affairs Manager
3 weeks ago
Singapore Integrity Partners Pte. Ltd. Full timeAs a Regulatory Affairs Manager, your primary responsibility will be to lead submission processes and streamline regulatory procedures to secure product approvals across the APAC/Asia/ASEAN markets. Moreover, you will be tasked with fostering collaboration and ensuring compliance with regional regulations.Role OverviewLead the coordination of submission...
-
Regulatory Affairs Manager
1 week ago
Singapore Respironics Inc Full timeJob TitleRegulatory Affairs ManagerJob DescriptionPhilips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.But it's not just what we do, it's who we are. We are 80,000, wonderfully unique...
-
Regulatory Affairs Manager
Found in: beBee S SG - 3 weeks ago
Singapore Philips Full timeJob TitleRegulatory Affairs ManagerJob DescriptionPhilips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.But itâs not just what we do, itâs who we are. We are 80,000, wonderfully...
-
Regulatory Affairs Manager
Found in: beBee jobs SG - 2 weeks ago
Singapore Philips Full timeJob TitleRegulatory Affairs ManagerJob DescriptionPhilips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.But it's not just what we do, it's who we are. We are 80,000, wonderfully unique...
-
Regulatory Affairs Manager
3 weeks ago
Singapore Integrity Partners Pte. Ltd. Full timeRepresenting a leading force in the pharmaceutical industry, our client is dedicated to pioneering life-saving therapies. We are currently seeking a talented Regulatory Affairs Manager to join their team, where you'll play a pivotal role in leading regulatory efforts. This position requires a blend of technical expertise and strategic acumen to navigate...
-
Regulatory Affairs
Found in: Talent SG 2A C2 - 4 days ago
Singapore PHARMENG TECHNOLOGY PTE. LTD. Full timeRoles & ResponsibilitiesSingapore/Pharmaceutical Division (6-month contract)Job PurposeTo contribute as an integral member of Client’s Singapore RA team to support all regulatory activities for Client’s products. This includes the development and implementation of regulatory strategies, including the review, preparation of submissions, required to secure...
-
Senior Regulatory Affairs
Found in: beBee jobs SG - 2 weeks ago
Singapore - Remote Oatly AB Full timeResponsibilities:Ensures legal compliance of company products and the activities with local guidelines and codes (including but not limited to product naming, labelling, packaging design, product selling point and advertising/promotion materials) Provide expertise and assessment comments on regulations applying to new launched products as well as...
-
Assistant Manager
Found in: Talent SG 2A C2 - 3 weeks ago
Singapore ABIORES PTE. LTD. Full timeRoles & ResponsibilitiesAssistant Manager / Manager, Regulatory AffairsAbout CorDx:CorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,000 employees across the world, serving millions of users in over 100 countries.CorDx is transforming the global diagnostics industry with...