Regulatory Affairs Officer

SRS Life Sciences Pte Ltd; Taguig; Hybrid; PHP 600,000 - 900,000; Full time

Benefits offered by this job

Attractive compensation package

Cross-functional collaboration across

Autonomy and responsibility

Supportive team environment

Job summary

SRS Life Sciences Pte Ltd in Taguig, Metro Manila, Philippines, seeks an experienced Regulatory Affairs Officer to manage regulatory submissions across Drug, Medical Device, Food Supplements and Cosmetic products. The role requires knowledge of ICH requirements, and ability to drive dossiers with cross-functional teams.

The ideal candidate has 4–5 years in regulatory roles within the Life Sciences industry, a licensed Bachelor’s in Pharmacy/Pharmacology, and a Master’s degree is preferred.

Qualifications

• Bachelor’s in Pharmacy/Pharmacology with a valid license.
• Master’s degree in Pharmacy is preferred.
• Minimum 4–5 years of regulatory experience in pharmaceutical companies.
• Experience with regulatory submissions for drugs, devices, and cosmetics is advantageous.

Responsibilities

• Coordinate, document, compile, and prepare dossiers for regulatory submissions.
• Develop and implement regulatory strategy and negotiations with Regulatory Authorities.
• Communicate with regulatory authorities and cross-functional teams to ensure compliance.
• Manage multiple projects and ensure timely regulatory submissions and approvals.

Skills

Regulatory affairs

Dossier preparation

Cross-functional collaboration

Communication skills

Project management

Education

Bachelor’s in Pharmacy/Pharmacology

Master of Science in Pharmacy

Tools

e-dossier management system

Excel

PowerPoint

Word processing

Job description

We are seeking: An experienced Regulatory Affairs Officer with comprehensive knowledge of regulatory processes and at least 5 years of experience in preparing and managing drug dossiers.

We offer:

• Attractive compensation package, to be discussed during interview and based on experience

• Cross-functional collaboration across local and international teams

• High level of autonomy and responsibility

• Collaborative and supportive team environment

As Regulatory Affairs Officer, you will play a critical role in ensuring that our Drug, Medical Device, Food Supplements and Cosmetic products adhere to all applicable regulations and standards, including ICH requirements and regional requirements. This role requires a deep understanding of regulatory guidelines and the ability to effectively communicate with regulatory authorities, cross-functional teams, and external partners. This role involves coordinating, documenting, compiling, and preparing dossiers for submission to regulatory agencies. The ideal candidate will be detail-oriented, proactive, and capable of managing multiple projects to ensure successful regulatory submissions, approvals and compliance.

Tasks and Requirements:

• Familiarity and experience with Drugs, Food Products, Food supplements, Herbal, Traditional medicines, Pre-biotics, Probiotics, devices, and other hospital / healthcare practices.

• Knowledge of standard office software programs including e-dossier management system, spreadsheet, word-processing, email applications, and PowerPoint.

• Substantial experience and understanding of the role of RA and regulatory requirements in the Life Sciences Industry including ICH requirements and regional requirements and understanding of current trends in the local market.

• Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities.

• Good project management skills with the ability to prioritize and multitask.

• Strong collaborative skills and ability to work well with internal cross-functional teams and external stakeholders.

• Excellent decision-making skills: make important decisions that impact the department and ensure they are proactively and appropriately communicated.

• Good communication skills, especially as it relates to transparency, collaboration, and the ability to work across communication channels.

• Self-motivated, able to work independently, enjoy a good challenge, and remains focused even in the face of setbacks.

• A flexible "can do" attitude is needed to thrive in an ambitious and fast-growing company.

• Flexible, determined, eager to experiment, and has an open mind.

• Showing initiative and ownership in their work to ensure a independent and reliable way of working

• High levels of integrity and honesty.

Minimum Qualification:

Bachelor’s in Pharmacy/Pharmacology, with registered license.

Additional Qualification (preferred):

Master of Science in Pharmacy

Years of Experience:

Minimum 4-5 years Regulatory Experience in Pharmaceutical companies

Language Preference:

English