Drug RA Manager

1 week ago

Singapore OASIS BIO PTE. LTD. Full time
Roles & Responsibilities

Job Summary:
We are seeking a highly motivated and detail-oriented Drug Regulatory Affairs Specialist to join our growing team. In this role, you will be responsible for managing the drug registration process for our innovative pharmaceuticals across Southeast Asia, with a primary focus on Singapore and Malaysia. You will work closely with internal teams and regulatory agencies to ensure timely and accurate submissions. Additionally, you will stay up-to-date on evolving regulatory requirements in the region and proactively identify and address potential issues.

Responsibilities:

  1. Document Preparation and Submission:
    • Lead the preparation and submission of drug registration applications, ensuring compliance with regulatory guidelines in Singapore and Malaysia.
    • Collaborate with internal teams to gather necessary documentation for registration submissions.
    • Ensure adherence to local regulatory requirements throughout the application process.
  2. Manage Drug Registration Process:
    • Develop and execute regulatory strategies for drug registration submissions to health authorities in Southeast Asia, particularly Singapore's Health Sciences Authority (HSA) and Malaysia's National Pharmaceutical Regulatory Agency (NPRA).
    • Oversee the drug registration process, including obtaining marketing authorizations and licenses.
    • Interact with regulatory agencies to address questions and clarifications during the registration review process.
  3. Regulatory Oversight:
    • Proactively monitor regulatory changes and updates in Singapore, Malaysia, and other Southeast Asian markets, assessing their impact on existing and planned programs.
    • Prepare and present regulatory documentation to internal stakeholders, including senior management.
  4. Record Keeping and Progress Tracking:
    • Maintain detailed records and track the progress of drug registration applications.
    • Work closely with internal teams to ensure that regulatory documentation supports product development and commercialization efforts.
    • Conduct regulatory assessments and gap analyses to identify and address compliance issues.
  5. Risk Management:
    • Identify and manage potential regulatory risks and proactively develop mitigation strategies.
  6. Communication:
    • Act as the primary point of contact for regulatory agencies in Singapore and Malaysia during the drug registration process.
    • Provide timely updates to internal stakeholders on the status of regulatory submissions and approvals.
    • Participate in regulatory meetings, addressing queries and providing necessary information.
  7. Cross-functional Collaboration:
    • Collaborate with cross-functional teams, including Quality Assurance and Manufacturing, to align regulatory activities with overall business objectives.
    • Provide regulatory guidance to support the development and implementation of nonclinical development plans.

Qualifications:

  1. Master’s degree in Regulatory Affairs, Pharmacy, Pharmacology, or a related field.
  2. Minimum of 3 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
  3. Strong understanding of regulatory guidelines and requirements in Singapore, Malaysia, and other Southeast Asian countries.
  4. Excellent written and verbal communication skills, with the ability to communicate complex regulatory information clearly and concisely to diverse audiences.
  5. Proven ability to manage multiple projects simultaneously and meet deadlines.
  6. Detail-oriented and highly organized, with strong analytical and problem-solving skills.
  7. Ability to work independently and as part of a team.
  8. Proactive and self-motivated, with a passion for regulatory affairs.
  9. Fluent in oral and written English and Chinese

Tell employers what skills you have

Pharmaceutical Industry
Assessing
Ability To Work Independently
Quality Assurance
Regulatory Affairs
Risk Management
Clinical Development
IND
Commercialization
Pharmacology
Product Development
Regulatory Requirements
Regulatory Submissions
Manufacturing

  • RA Manager

    1 week ago

    Singapore BEATHCHAPMAN (PTE. LTD.) Full time

    Roles & ResponsibilitiesFollowing a year of success, an Asian Pharma company is looking to start their second phase of growth after entering Singapore just last year. They are currently looking for a Regulatory Affairs Manager to drive registration approvals across SEA for their products. The work has already started, and they have a long list of products...

  • Executive Culinary Director

    5 days ago

    Singapore KKO KKO NA RA PTE. LTD. Full time

    Culinary Leadership Opportunity at KKO KKO NA RA PTE. LTD.KKO KKO NA RA PTE. LTD. is seeking an exceptional Executive Culinary Director to lead our culinary team and shape the future of our restaurant.About the Role:We are looking for a seasoned Chef Manager with a passion for innovation and a commitment to excellence. As our new Executive Culinary Director,...

  • Restaurant Operations Manager

    1 week ago

    Singapore KKO KKO NA RA PTE. LTD. Full time

    Job Title: Restaurant Operations ManagerKKO KKO NA RA PTE. LTD. is seeking a seasoned Restaurant Operations Manager to oversee the daily sales operations, drive business growth, and lead a high-performing team.About the Role:Oversight of restaurant sales operations, including managing inventory, implementing sales strategies, and driving revenue...

  • Sales Operations Director

    7 days ago

    Singapore KKO KKO NA RA PTE. LTD. Full time

    Job Title: Sales Operations DirectorWe are looking for an experienced and skilled individual to take on the role of Sales Operations Director at KKO KKO NA RA PTE. LTD. The ideal candidate will have a proven track record in managing daily sales operations, promoting business growth, and improving profitability.About the Role:In this key position, you will be...

  • Drug Design Chemist Position for NTU

    7 days ago

    Singapore NTU (Nanyang Technology University- MainOffice-HR) Full time

    The Centre for Antimicrobial Bioengineering at the School of Chemical and Biomedical Engineering, Nanyang Technological University in Singapore is seeking a Synthetic Drug Chemist to join their team.Key ResponsibilitiesThe Research Fellow will assist with managing the centre, including procurement, lab safety, proposal preparation, and technical report...

  • Restaurant Operations Director

    5 days ago

    Singapore KKO KKO NA RA PTE. LTD. Full time

    Job DescriptionWe are seeking an experienced Sales Management Professional to join our team at KKO KKO NA RA PTE. LTD.Key Responsibilities:Oversee Daily Restaurant Sales Operations: Direct and manage the daily sales operations of our restaurant, ensuring maximum profitability and efficiency.Promote and Market the Business: Develop and implement effective...

  • Principal investigator

    3 weeks ago

    Singapore Agency For Science, Technology And Research Full time

    Principal Investigator in AI in Drug Discovery Program, Bioinformatics Institute (A*STAR)Job description:We are seeking an AI/ML expert to drive AI in drug discovery in the area of pharmacology and pharmacometrics, including PK/PD, in the Bioinformatics Institute (BII). He/She will build a research group in BII and collaborate closely with clinicians and...

  • Regulatory affairs manager

    2 weeks ago

    Singapore Baxter Healthcare Full time

    Vantive: A New Company Built on Our LegacySince last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership...

  • Regulatory affairs manager

    2 weeks ago

    Singapore Baxter Healthcare Full time

    Vantive: A New Company Built on Our LegacySince last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership...

  • Senior Principal Scientist

    1 week ago

    Singapore A*STAR RESEARCH ENTITIES Full time

    Roles & ResponsibilitiesJob Description:We are seeking an AI/ML expert to drive AI in drug discovery in the area of pharmacology and pharmacometrics, including PK/PD, in the Bioinformatics Institute (BII) and Experimental Drug Development Centre (EDDC). The PI will build a research group in BII and collaborate closely with clinicians and researchers to drive...

  • Senior Principal Scientist

    2 days ago

    Singapore Agency for Science, Technology and Research (A*STAR) Full time

    Job Description: We are seeking an AI/ML expert to drive AI in drug discovery in the area of pharmacology and pharmacometrics, including PK/PD, in the Bioinformatics Institute (BII) and Experimental Drug Development Centre (EDDC). The PI will build a research group in BII and collaborate closely with clinicians and researchers to drive this effort across...

  • Executive Culinary Director

    5 days ago

    Singapore KKO KKO NA RA PTE. LTD. Full time

    Job DescriptionWe are seeking an exceptional Executive Culinary Director to lead our culinary team at KKO KKO NA RA PTE. LTD.About the Role: The successful candidate will be responsible for controlling and directing the food preparation process, ensuring high-quality dishes are consistently delivered to our customers. They will construct menus with new or...

  • Executive Culinary Director

    1 week ago

    Singapore KKO KKO NA RA PTE. LTD. Full time

    Job DescriptionThis is a high-level leadership role responsible for overseeing the culinary operations of a prestigious restaurant.Responsibilities:Develop and implement menus that showcase creativity and quality, ensuring a diverse range of options for customers.Direct the food preparation process, ensuring timely delivery of dishes to meet customer...

  • Executive Head Chef

    7 days ago

    Singapore KKO KKO NA RA PTE. LTD. Full time

    Job DescriptionWe are seeking an experienced Executive Head Chef to join our team at KKO KKO NA RA PTE. LTD.About the RoleThe successful candidate will be responsible for leading our culinary team, driving menu innovation and quality, and ensuring exceptional customer satisfaction.Key ResponsibilitiesMenu Development: Define menu concepts, update dishes, and...

  • Senior Principal Scientist

    2 weeks ago

    Singapore A*star Research Entities Full time

    JobDescription:We are seeking anAI/ML expert to drive AI in drug discovery in the area ofpharmacology and pharmacometrics, including PK/PD, in theBioinformatics Institute (BII) and Experimental Drug DevelopmentCentre (EDDC). The PI will build a research group in BII andcollaborate closely with clinicians and researchers to drive thiseffort across Singapore....

  • Executive Culinary Director

    1 week ago

    Singapore KKO KKO NA RA PTE. LTD. Full time

    About the RoleWe are seeking an accomplished Executive Culinary Director to spearhead our culinary team at KKO KKO NA RA PTE. LTD. This is a fantastic opportunity for a seasoned professional to lead our kitchen operations and drive menu innovation.ResponsibilitiesCulinary Visionary: Define and execute menu concepts that showcase exceptional taste,...

  • Executive, regulatory affairs

    2 weeks ago

    Singapore B. Braun Melsungen AG Full time

    You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency, and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in...

  • Regional Study Coordinator

    6 days ago

    Singapore Labcorp Drug Development Full time

    Responsibilities / Duties: In this role you will be responsible for managing clinical projects to ensure the successful delivery of all lab services, including kits shipment, sample testing and sample management of a clinical study for the Asia region Act as regional liaison between Labcorp Central Lab Services (CLS) Global Study Manager and various CLS...

  • Process excellence lead

    1 month ago

    Singapore Labcorp Drug Development Full time

    As a certified Black Belt (or equivalent), you will act as the Process Excellence local point of contact to support local Continuous Improvement initiatives, partnering with local teams and liaise with the global Process Excellence team to guarantee methods consistency, prioritization and leverage the Process Excellence team bandwidth. This position is an...

  • Medical technologist

    3 weeks ago

    Singapore Labcorp Drug Development Full time

    Job Level & compensation offered may vary depending on candidates’ experiences and competencies. Responsibilities: Incumbent performs established procedures for clinical testing as required in all assigned laboratory disciplines. Incumbent is responsible for analyzing specimens whose results are then reported to the sponsor. Incumbent proactively seeks...