Senior Regulatory Specialist/ Regulatory Consultant (Clinical), Therapeutic at Public Service Division

, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

21 Aug, 26

Salary

0.0

Posted On

23 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Evaluation, Regulatory Affairs, Technical Writing, Stakeholder Management, Policy Development, Clinical Data Analysis, Relationship Building, Scientific Communication, Regulatory Framework Interpretation, Project Management

Industry

IT Services and IT Consulting

Description

[What the role is] Clinical evaluation of therapeutic product registration submissions [What you will be working on] Evaluate clinical data submitted by pharmaceutical companies and provide technical advice on data requirements for therapeutic product registration applications. Develop scientific opinions and position papers on evolving regulatory approach and technical requirements. Represent HSA at external engagements, including meeting with sponsors, technical and advisory committees. Foster partnership with international regulatory authorities through collaborative review and information sharing activities. Serve as HSA's technical expert and front scientific discussions for workshare projects with international regulators. Represent HSA at international regulatory forums, contributing to development of regulatory guidelines and standards. [What we are looking for] A background in Medicine, Pharmacy or related discipline with relevant experience in immunology or oncology. RELEVANT EXPERIENCE Minimum 7 - 10 years' experience in clinical pharmacy, medical practice, or clinical-related regulatory work. Professional background in clinical practice or research, with knowledge of clinical practice guidelines. Good understanding of pharmaceutical legislation and regulatory frameworks, with the ability to interpret and apply complex scientific and clinical information to inform regulatory and policy decisions. Experience in supporting policy development initiatives, process improvements and contributing to policy decisions. RELEVANT SKILLS Excellent written and verbal communication abilities with attention to detail and the capacity to convey scientific matters clearly to diverse audiences, including senior decision-makers. Strong relationship-building skills with the ability to engage effectively with diverse stakeholders and foster productive collaborative partnerships across various sectors. Ability to analyse and integrate different sources of information to develop solutions. Ability to take responsibility for individual and team performance, monitor workflow progress and consistently deliver quality outcomes within demanding timeframes whilst maintaining high standards. Highly motivated with strong desire to protect public health and safety. The successful candidate will be offered a 1-year contract (with option for automatic renewal for a further one year) in the first instance. Shortlisted candidates would be contacted within 30 days from the closing date of the advertisement. We regret that only shortlisted candidates would be notified. http://jobs.careers.gov.sg The Singapore Public Service plays a key role in the economic growth, progress and stability of Singapore by formulating and implementing government policies, as well as providing key public services. Whether you are a fresh graduate joining the workforce or an experienced professional, the Singapore Public Service offers a great variety of job opportunities for you. The work in the Public Service can be broadly categorised into the following sectors: Economic, Social, Security & External Relations, and Administration & Corporate Development. Be part of the team that shapes the future of Singapore. Log on and take your first step towards a career that matters! Need help? Please click here for assistance. Our team will contact you shortly!

Responsibilities

Evaluate clinical data for therapeutic product registration submissions and provide technical advice to pharmaceutical companies. Represent the agency at international regulatory forums and collaborate with global authorities to develop regulatory guidelines.