Regulatory Affairs Manager, Malaysia and Singapore

GMP Technologies; Kuala Lumpur; Presencial; MYR 180 000 - 320 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Comprehensive health benefits

Career development opportunities

Collaborative work environment

Performance-based bonus

Resumo da oferta

GMP Technologies is seeking a highly skilled Regulatory Affairs Manager to oversee the registration of pharmaceutical products in Singapore and Malaysia. The successful candidate will ensure compliance with all regulatory requirements and facilitate the timely approval of new and existing drugs.

Key responsibilities include preparing, compiling, and submitting regulatory dossiers to the Health Sciences Authority in Singapore and the NPRA in Malaysia, monitoring submissions, guiding

Qualificações

• Bachelor's degree in Pharmacy or Life Sciences; Master’s preferred.
• Minimum 5 years in regulatory affairs with drug registration experience in Singapore and Malaysia.
• Strong knowledge of regulatory requirements and submission processes in both countries.
• Excellent communication and cross-functional collaboration skills.

Responsabilidades

• Manage end-to-end drug registration processes for Singapore and Malaysia.
• Prepare, compile, and submit regulatory dossiers to HSA and NPRA.
• Monitor submissions and respond to regulatory queries promptly.
• Ensure compliance with local regulations, guidelines and standards.
• Liaise with internal teams and external bodies to streamline registrations.
• Keep updated on regulatory changes and advise stakeholders.

Conhecimentos

Regulatory affairs

Project management

Communication skills

English proficiency

Formação académica

Bachelor's degree in Pharmacy or Life Sciences

Master's degree preferred

Descrição da oferta de emprego

Regulatory Affairs Manager, Malaysia and Singapore

Job Openings Regulatory Affairs Manager, Malaysia and Singapore

About the job Regulatory Affairs Manager, Malaysia and Singapore

Job Title: Regulatory Affairs Manager

Location: Malaysia

Job Type: Full-Time

Job Summary: We are seeking a highly skilled and experienced Regulatory Affairs Manager to oversee the registration of pharmaceutical products in Singapore and Malaysia. The successful candidate will ensure compliance with all regulatory requirements and facilitate the timely approval of new and existing drugs.

Key Responsibilities:

• Manage the end-to-end process of drug registration in Singapore and Malaysia.
• Prepare, compile, and submit regulatory dossiers to the Health Sciences Authority (HSA) in Singapore and the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia.
• Monitor and track the progress of regulatory submissions and address any queries from regulatory authorities promptly.
• Ensure compliance with local regulations, guidelines, and standards for pharmaceutical products.
• Liaise with internal teams, external partners, and regulatory bodies to ensure smooth and efficient registration processes.
• Stay updated on changes in regulatory requirements and communicate these changes to relevant stakeholders.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Quality Assurance, and Marketing.
• Conduct risk assessments and develop strategies to mitigate regulatory risks.
• Maintain accurate and up-to-date records of all regulatory activities and documentation.

Qualifications:

• Bachelor's degree in Pharmacy, Life Sciences, or a related field. A Master's degree is preferred.
• Minimum of 5 years of experience in regulatory affairs, with a focus on drug registration in Singapore and Malaysia.
• In-depth knowledge of regulatory requirements and submission processes in both countries.
• Strong project management skills and the ability to handle multiple projects simultaneously.
• Excellent communication and interpersonal skills.
• Proficiency in English; knowledge of additional languages is a plus.
• Detail-oriented, proactive, and able to work independently.
• Competitive salary and performance-based bonuses.
• Comprehensive health and wellness benefits.
• Opportunities for professional development and career advancement.
• Collaborative and inclusive work environment.

This is in partnership with the Employment and Employability Institute Pte Ltd (e2i).

e2i is the empowering network for workers and employers seeking employment and employability solutions. e2i serves as a bridge between workers and employers, connecting with workers to offer job security through job-matching, career guidance and skills upgrading services, and partnering employers to address their manpower needs through recruitment, training, and job redesign solutions. e2i is a tripartite initiative of the National Trades Union Congress set up to support nation-wide manpower and skills upgrading initiatives.