Senior Ra Specialist

5 days ago

Singapore Hologic Full time

Support the commercial organization and dealers/partners in ASEAN/South Asia to ensure their timely new product launches and sustainable registrations success.
Manage communications and documentation between Business Units, distributors, regional head office and divisional RA, and manufacturing.
- Ensure that regulatory activities are aligned with commercial priorities, providing necessary insights and guidance to integrate regulatory needs into business strategies.
- Lead timely and regular updates with the commercial, regulatory and management team on any changes in regulations related to pre-market/registration requirements that may have a material impact on the business.
- Identify any potential issues that may impact the regulatory strategy and timeline for products registrations and develop and propose solutions to mitigate the risk and outcome.
- Ensure all registration activities meet internal and external deadlines, ensuring alignment with business priorities.
- Manage the product registration projects for all of ASA.
- Support the commercial team on tender and operational issues.
- Support the development of regulatory strategies for new product launches and market expansions in the region.
- Identify potential regulatory challenges that may impact product registration timelines and propose solutions to mitigate risks.
- Drive continuous improvement in regulatory processes to ensure compliance with the latest regulations and optimize registration efficiency.
- Maintain and develop a Regulatory intelligence database and be capable of analyzing the information available.
- Monitor and assess changes in local and international regulatory requirements, ensuring that the organization is prepared and compliant with evolving regulations.
- Provide regular updates such as monthly report/tracker to the commercial and leadership teams and any significant regulatory changes or action that may impact the business.
- Maintain records, tracking, master data, monthly reporting and documents related to the ASA region.
- Provide regulatory expertise and guidance to commercial and cross-functional teams in the region.
- Review, improve, maintain the processes to meet corporate and latest/prevailing regulatory requirements.
- Any other duties as assigned by the manager
- A bachelor’s degree in pharmacy, biomedical sciences or related
- Postgraduate degree as well as regulatory proficiency based on certifications is highly desired.
- Minimum 5-years’ experience within the medical device or IVDs industry.
- Proven product registration success track record across multiple product lines.
- Good knowledge of current global (EU MDD/MDR and IVDR, US FDA) and ASA regulatory requirements.
- Regional RA experience, with existing experience covering at least 2-3 ASEAN countries
- Multi-national company experience with specific success working for US or European based companies.
- Strong analytical and critical thinking skills to interpret complex regulations and determine the appropriate action.
- Strong problem-solving skills and attention to detail.
- Develop and maintain positive relationships with relevant stakeholders.
- Excellent communication skills with ability to effectively interact at all levels as well as cross-cultural awareness.
- Good oral and written English skill. Proficiency in another Asian language will be advantageous.

  • Ra Specialist

    3 days ago

    Singapore Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a RA Specialist located in Singapore. Position Summary As an APJ Veeva Coordinator, primary responsibility is to ensure the smooth operation and effective use of the Veeva system within the organization. The Veeva system is a copy clearance approval system for advertisement and promotional material, and local...

  • Regulatory Affairs

    1 week ago

    West Singapore Emprego SG Full time

    **Location** - Singapore, West**Job Type** - Permanent**Salary** - $3,500 - $8,000 Per Month**Date Posted** - 59 minutes agoAdditional Details **Job ID** - 97191**Job Views** - 6Roles & Responsibilities We are a global leader in the manufacturing of medical devices and delivering solutions to improve lives through today’s technology and future...

  • Regulatory Affairs

    1 week ago

    Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    Singapore/Pharmaceutical Division **Job Purpose** To 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 regulatory approval across various...

  • QA/ra Specialist

    3 days ago

    Singapore OPTO-PHARM PTE LTD Full time

    **POSITION PURPOSE**: This individual is responsible for the processing all regulatory affairs matter related to the product life cycle from premarket to post market activities, advising the team on appropriate regulatory procedures to ensure products are legally marketed in the respective country. The incumbent is responsible to draft a regulatory...

  • Social Media

    1 week ago

    Singapore KKO KKO NA RA PTE. LTD. Full time

    **About Us** Since 2008, we’ve grown from Singapore’s first Korean fried chicken restaurant into a multi-brand group Hansik Dining Collective : Kko Kko Na Ra, The Gogi Jip, Halmae Gukbap, Hanyang Bulgogi, Chungsa Chorong, based at **33 Tras Street**. With more openings ahead, we’re expanding our in-house content & marketing team. **Role Title** Social...

  • Senior Specialist/specialist, Regulatory Affairs

    2 days ago

    Singapore Boston Scientific Corporation Full time

    **Senior Specialist/Specialist, Regulatory Affairs Support APAC (1 year contract)**: - Remote Eligible: Hybrid- Onsite Location(s): Singapore, SG**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of...

  • Senior / Regional Regulatory Affairs Specialist [pharma / Up to 6k]

    1 week ago

    Singapore INTEGRITY PARTNERS PTE. LTD. Full time

    An excellent opportunity has come up with an international Pharmaceutical MNC and they are currently looking for a **Senior / Regional Regulatory Affairs Specialist**to join the team in Singapore. The successful incumbent will drive the implementation of global guidelines and work alongside local RA functions to ensure product approvals. You will also...

  • Aspac Ra Regional Lead

    2 days ago

    Singapore Johnson & Johnson Full time

    The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through...

  • Senior / Regional Regulatory Affairs Specialist Pharma / Up to 6K

    2 weeks ago

    Singapore Integrity Partners Full time $80,000 - $120,000 per year

    An excellent opportunity has come up with an international Pharmaceutical MNC and they are currently looking for a Senior / Regional Regulatory Affairs Specialist to join the team in Singapore.The successful incumbent will drive the implementation of global guidelines and work alongside local RA functions to ensure product approvals. You will also exhibit...

  • Specialist, Regulatory Affairs

    2 weeks ago

    Singapore Resmed Full time

    Position Specialist, Regulatory Product Strategy & Delivery – Singapore (Regulatory Affairs)Overview Regulatory Affairs at ResMed is central to ensuring timely and compliant access to global markets. The Singapore RPSD team leads regulatory strategy and delivery for products where ResMed Singapore is the legal manufacturer, supporting New Product...