Drug Regulatory Affairs Specialist

2 weeks ago

Singapore DADACONSULTANTS PTE. LTD. Full time

**Responsibilities**:
1. Lead Document Preparation and Submission:

- Collaborate with internal teams to gather necessary documentation for IND submissions.

2. Manage Drug Registration Process:

- Develop and execute regulatory strategies for drug registration submissions to health authorities.
- Oversee the drug registration process, including obtaining marketing authorizations and licenses.

3. Regulatory Oversight:

- Proactively monitor regulatory changes and updates, assessing their impact on existing and planned programs.
- Prepare and present regulatory documentation to internal stakeholders, including clinical teams and senior management.

4. Record Keeping and Progress Tracking:

- 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
- 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 Clinical Development, Quality Assurance, and Manufacturing, to align regulatory activities with overall business objectives.
- Provide regulatory guidance to support the development and implementation of clinical and 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 local and international regulatory guidelines for clinical trial approval and drug registration, especially FDA.

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.
- Send me your resume via WhatsApp ❤

Data provided is for recruitment purposes only Business Registration Number: 201735941W. Licence Number: 18S9037

  • Regulatory Affairs Specialist

    1 week ago

    Singapore Johnson & Johnson Full time

    Johnson & Johnson is currently seeking a Regulatory Affairs Specialist to join our Regulatory Affairs team located in Singapore. : The Regulatory Affairs Specialist is a member of the Local Operating Company (LOC) Regulatory Affairs team and is responsible for preparation of life cycle management submissions to the Health Authority. Globally dispatched life...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore Johnson & Johnson Full time

    The Regulatory Affairs Specialist (MD) is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices products under their responsibility. - The Regulatory Affairs Specialist (MD) will be a member of the local regulatory affairs department within Johnson...

  • Regulatory Affairs Specialist

    4 weeks ago

    Singapore ALCOTECH PTE. LTD. Full time

    Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia. Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore ALCOTECH PTE. LTD. Full time $49,300 - $63,500 per year

    Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.Role OverviewWe are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...

  • Medical and Regulatory Affairs Head

    2 weeks ago

    Singapore Novo Nordisk Full time

    Medical and Regulatory Affairs Head **Category**:Medical Affairs **Location**:Singapore, Singapore, SG **About the department** In Novo Nordisk, the Medical and Regulatory Affairs secure the approval of new multibillion-dollar products and drug indications, making it possible for the company to bring innovative products to patients. We stand at the centre...

  • Regulatory Affairs Personnel

    1 week ago

    Singapore HAATON CAPITAL PTE. LTD. Full time

    The Regulatory Affairs (RA) Personnel contributes to the regulatory function by registering, attaining and maintaining marketing authorisation of therapeutic products. Key Responsibilities - Prepare and review registration dossiers for submission to drug regulatory agency - Coordinate with overseas suppliers and partners to ensure accurate and complete...

  • Regional Regulatory Affairs Manager

    2 weeks ago

    Singapore TMS Talent Full time

    **Location**: Singapore Job highlights The opportunity to make a real impact. Immediately Interview Work in a fast-paced and exciting environment Our client's innovations are transforming healthcare. They need an experienced Senior Regulatory Affairs. You will lead Southeast Asia regulatory initiatives to ensure their varied pharmaceuticals and medical...

  • Regional Regulatory Affairs Specialist

    1 day ago

    Singapore Reeracoen Singapore Pte Ltd Full time

    Job title: Regional Regulatory Affairs Specialist Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regional Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and monitoring...

  • Surveillance Regulatory Affairs Officer

    1 day ago

    Singapore Marina Bay Sands Full time

    Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands 2 weeks ago Be among the first 25 applicants Join to apply for the Surveillance Regulatory Affairs Officer role at Marina Bay Sands Get AI-powered advice on this job and more exclusive features. LOVE WHAT YOU DO? THERE IS A PLACE FOR YOU HERE!Be part of our diverse and...

  • Regulatory Affairs Coordinator

    2 weeks ago

    Singapore ResMed Full time

    The Regulatory Affairs Coordinator supports the regulatory affairs team in ensuring compliance with local, regional, and international regulations for medical devices. This position involves assisting in the preparation of regulatory documents, maintaining records, and coordinating with various departments to support product registrations and regulatory...