Global Regulatory Affairs Specialist

7 days ago

Singapore beBeeRegulatoryAffairsSpecialist Full time $100,000 - $140,000
Job Description:

We are seeking a highly skilled Global Regulatory Affairs Specialist to oversee regulatory tasks related to new product development, securing registrations, and managing the product lifecycle in Japan.

  • To support our strategic objectives, you will develop and manage effective working relationships with regulatory authorities, stakeholders, and internal teams.
  • You will make decisions for regulatory strategy on each project from a technical perspective.
  • Support in the preparation of regulatory dossiers for submission to regulatory authorities in order to obtain registration of the products.
  • Provide tactical and strategic regulatory leadership to the team and manage all regulatory programs, including new product introduction, continuous improvement activities, and compliance-related projects.
Key Skills and Qualifications:
  • Bachelor's degree (science) minimum
  • 10+ years' experience leading Regulatory Affairs in the Nuclear Medicine or Pharmaceutical environment
  • Extensive experience in collaborating with regulatory authorities
  • Demonstrated knowledge of Regulatory and ICH guidelines
  • Strong experience with CTD/eCTD submissions in clinical and commercial regulatory filings
  • Strong communication skills, fluent in English (verbal and written)
Benefits:
  • Competitive salaries
  • Annual performance-based bonuses
  • Equity-based incentive program
  • Generous vacation time
  • Paid wellness days
  • Support for learning and development
What We Offer:
  • A dynamic work environment with a diverse group of colleagues
  • The opportunity to contribute to the success of a global company
  • A comprehensive benefits package
Seniority Level:
  • Director
Employment Type:
  • Full-time
Job Function:
  • Legal
  • Industries: Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Telix Pharmaceuticals Limited by 2x

Get notified about new Manager Global Regulatory Affairs jobs in Singapore, Singapore

Career Opportunities:
  • Senior Regulatory Affairs Manager- APAC- Remote
  • Principal Regulatory Compliance Specialist
  • Regulation Manager ILE - Sanctions Lists (Remote)
  • Identity Security - Sr Customer Success Manager - IAM/IGA - APAC
  • (Individual Contributor) Regional Sales Manager – Southeast Asia/Pacific Rim Region
  • Senior Product Manager (Security and Risk Control)
  • Technical Product Manager - Trading Infrastructure / DEX Build

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

Keyword: RegulatoryAffairsSpecialist

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore beBeeRegulatory Full time $80,000 - $120,000

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in regulatory affairs, excellent communication skills, and the ability to work effectively in a fast-paced environment.Job Description:Develop and implement regulatory strategies for new and existing...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore beBeeRegulatory Full time $90,000 - $120,000

    Job Title: Regulatory Affairs Specialist">A leading global Medical Device company is seeking a seasoned Regulatory Affairs professional to join their expanding team in Singapore.The ideal candidate will have extensive experience in RA/QA and a relevant science degree. They will be responsible for ensuring regulatory compliance, developing registration...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore beBeeRegulatory Full time

    Job Title: Regulatory Affairs Specialist "> A leading global Medical Device company is seeking a seasoned Regulatory Affairs professional to join their expanding team in Singapore. The ideal candidate will have extensive experience in RA/QA and a relevant science degree. They will be responsible for ensuring regulatory compliance, developing registration...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore ProductLife Group Full time

    We are looking for a highly motivated and detail-oriented Regulatory Affairs Specialist to join our consulting company. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products on a global scale.Your responsibilities will...

  • Regulatory Affairs Specialist

    5 days ago

    Singapore Johnson & Johnson Full time

    Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of...

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore beBeeRegulatory Full time $100,000 - $160,000

    Regulatory Affairs Specialist Job DescriptionThis is a comprehensive overview of the key responsibilities and deliverables for the Regulatory Affairs Specialist role.

  • Global Regulatory Affairs Manager

    7 days ago

    Singapore beBeeRegulatory Full time

    Regulatory Affairs Specialist Job Overview This is a key role within the organization responsible for all aspects of regulatory responsibilities in Singapore and Malaysia. The specialist will combine knowledge of scientific, regulatory, and business issues to enable products to meet required legislations in applicable markets. This includes directing and...

  • Regulatory Affairs Specialist

    1 week ago

    Singapore beBeeRegulatory Full time

    Regulatory Affairs Specialist Job Description This is a comprehensive overview of the key responsibilities and deliverables for the Regulatory Affairs Specialist role.

  • Regulatory Affairs Specialist

    2 weeks ago

    Singapore Johnson & Johnson Full time $80,000 - $120,000 per year

    Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of...

  • Regulatory Affairs Specialist

    6 days ago

    Singapore beBeeCompliance Full time $80,000 - $150,000

    Regulatory Affairs Specialist - Global Compliance ExpertiseJob Summary:This is an exciting opportunity to lead and manage regulatory submission timelines for new and existing products across key global markets.Establish and manage regulatory submission timelines for new and existing products across key global markets, ensuring compliance with international...