- Prepares submission dossier for post-approval variations focusing on site transfers, CMC variations, GMP certification activities and any other CMC or administrative related activities within agreed timelines
- Prepares monthly project status updates.
- Maintains knowledge of latest regulatory requirements for therapeutic products.
- Establish and maintain good working relationship with the HSA.
- Acts as primary RA contact for the local team for the projects assigned.
- Ensures new regulatory initiatives and changes are shared with the regional/global RA function in a timely manner with critical assessment of potential impact on business for the projects assigned.
- Investigate regulatory compliance gaps with gap remediation plan development and implementation thereafter.
- Develop and maintain regulatory database(s) as required
- Maintain and update regulatory files and records as required
- Ensures compliance with local regulations, corporate policies and procedures
- Prepares monthly project status updates
- Process CPP Applications as and when required.
- Support post-approval variations for various therapeutic areas (Singapore)
- Support process improvements and implementation of best practices
- Collaborates with local Quality Assurance (QA) on Quality matters
- A minimum of Bachelor's degree in health-related science, life science, Pharmacy degree desired
- 1-2 years of experience in regulatory affairs or related work experience.
- Proven track record of preparing and reviewing regulatory documentation, and managing submissions successfully
- Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of human medicinal products
- Good understanding of local regulatory environment, guidelines and processes for product registration.
- Ability to apply knowledge to general regulatory topics for projects assigned
- Computer literacy with knowledge of MS Office applications
- Good interpersonal, organizational, negotiation and problem solving skills
- Excellent verbal and written communication skills
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Regulatory Affairs Associate - Singapore - Pharmeng Technology Pte. Ltd.
Description
PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products. At PharmEng Technology, we strive to cultivate the best working environment where empowerment, passion and perseverance are nurtured while serving our clients to achieve their unique business goals. We are seeking an experienced Regulatory Affairs Associate with experience in pharmaceutical company/Life Science industries for a role in Singapore.
Responsibilities:
Qualifications:
Why PharmEng Technology
Our consultants come from different areas of the Pharmaceutical/Biotech/Medical Device industries and have extensive experiences obtained from world-class organizations in North America, Europe, and Asia. At PharmEng Technology, we value everyone's unique talents and work together to support our clients. We offer continuous career growth, competitive wages, opportunities for travel and a team mentality that sets us apart from our competitors. It is the growth of our staff that continues to grow our company globally.
EEOC Statement
At PharmEng Technology, we don't just accept difference - we celebrate it, we support it, and we thrive on it for the benefit of our employees, our clients, and our community. PharmEng Technology is proud to be an equal opportunity workplace.
