Job Purpose

To contribute as an integral member to Singapore RA team to support all regulatory activities. This includes the development and implementation of regulatory strategies, including the review, preparation of submissions, required to secure regulatory approval across various therapeutic areas, in alignment with core business objectives.

Regulatory Strategy
• Prepares submission dossiers for post-approval variations within agreed timelines.
• Maintains general knowledge of latest regulatory requirements.
• Establish and maintain good working relationship with internal and external stakeholders.
• Support investigation of regulatory compliance gaps with gap remediation plan development and implementation thereafter.
• Determine regulatory relevance and perform variation assessments.

Management of Regulatory operations
• 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 and verify monthly reports in addition to providing timely updates to relevant stakeholders.
• Receive, gather, assess, and process information received from assigned stakeholders.
• Provide administrative support where required.

Collaboration with cross-functional teams
• Support process improvements and implementation of best practices.
• Collaborates with Supply Chain Management Team on shipment matters when required.
• Collaborates with Quality Assurance (QA) Team on Quality matters (e.g. investigation of deviations and reporting them to relevant health authorities, when applicable), and Patient Safety (PS) on safety communication when required.
• Collaborates with RA Business & Operational Excellence on obtaining the required for regulatory submission.

Key Requirements
• Degree/Polytechnic Diploma, preferably in the Sciences (Pharmacy, Life Sciences, Biological Sciences etc)
• 1 year of experience in regulatory affairs or related work experience.
• Good knowledge and understanding of pharmaceutical & scientific processes.
• Good understanding of the regulatory environment, guidelines and processes for product registration.
• Attention to detail
• Ability to work with data and basic regulatory SOPs (learning agility and ability to learn independently/on the role will be a big plus)
• Takes ownership of tasks and strong ability to collaborate with team members

Ideal Background

Education (minimum/desirable):

BSc in health-related science, life science, Pharmacy degree desired

Languages:

English - fluent in speaking and writing.

We regret that only shortlisted applicants will be notified.

Job Summary:

We are seeking a highly motivated and skilled Pharmaceutical Engineer to join our team. The successful candidate will play a pivotal role in the design, development, and manufacturing of pharmaceutical products. This position requires a deep understanding of pharmaceutical processes, regulatory compliance, and quality assurance. If you are a dedicated professional with a passion for ensuring the safety and efficacy of pharmaceutical products, we encourage you to apply.

Key Responsibilities:

1. Drug Formulation: Collaborate with cross-functional teams to develop drug formulations, select suitable excipients, and optimize drug delivery systems.
2. Process Development: Design, scale-up, and optimize pharmaceutical manufacturing processes to ensure efficiency, quality, and compliance with regulatory standards.
3. Quality Control: Develop and implement quality control methods and protocols to monitor and ensure product quality throughout the manufacturing process.
4. Regulatory Compliance: Stay up-to-date with pharmaceutical regulations (e.g., FDA, EMA) and ensure that all manufacturing processes and products adhere to relevant standards.
5. GMP Adherence: Maintain adherence to Good Manufacturing Practices (GMP) and develop and update standard operating procedures (SOPs) as needed.
6. Validation: Develop and execute validation protocols for manufacturing processes, equipment, and facilities to ensure consistent product quality.
7. Research and Development: Participate in R&D activities, conduct experiments, analyze data, and contribute to the development of new drug compounds or dosage forms.
8. Equipment and Facility Management: Select, install, and maintain pharmaceutical manufacturing equipment and facilities to ensure compliance with regulatory requirements.
9. Documentation: Maintain accurate and comprehensive documentation of all processes, experiments, and validations for regulatory purposes.
10. Collaboration: Work collaboratively with multidisciplinary teams, including chemists, pharmacists, regulatory affairs specialists, and quality control professionals.
11. Continuous Improvement: Identify opportunities for process optimization, cost reduction, and quality enhancement, and implement improvements accordingly.

Qualifications:

• Bachelor's or higher degree in pharmaceutical engineering or any engineering related field.
• 5 years + of experience in pharmaceutical manufacturing or process development.
• Strong knowledge of pharmaceutical regulations, including GMP and FDA guidelines.
• Proficiency in data analysis and statistical tools.
• Excellent communication and teamwork skills.
• Detail-oriented with a commitment to quality and safety.
• Problem-solving and critical thinking abilities.

Preferred Qualifications:

• Bachelor's Degree in pharmaceutical engineering or any engineering related field.
• Experience with regulatory submissions and interactions with regulatory agencies.
• Knowledge of pharmaceutical equipment and facility design.
• Familiarity with process simulation software.
• Project management skills.

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:

• Prepares monthly project status updates.
• Maintains knowledge of latest regulatory requirements for therapeutic products.
• 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
• 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

Qualifications:

• 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

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.

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 Validation Engineer with experience in pharmaceutical company/Life Science industries for a role in Singapore.

Proficient in the following:

1. Software upgrade qualification

2. Empower

3. Temperature mapping

4. Data integrity

Requirements

• 3-5 years minimum experience in software validation
• Preferred someone who has experience with QC Software validation and temperature mapping
• Fluent in English

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.

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We'd love you to apply for this full-time Technical Lead position in Singapore, and we're waiting to hear from you. Don't hesitate to get in touch with Cognizant today.

At Cognizant, we engineer modern businesses to improve everyday life because we're dedicated to making a lasting impact. Cognizant (Nasdaq: CTSH) engineers modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast-changing world. Together, we're improving everyday life. See how at www.cognizant.com or @cognizant.