Regulatory Affairs Officer

About the role

As a , you will play a pivotal role in ensuring that our healthcare products comply with all relevant regulations and standards. This position is essential for maintaining the integrity of our product offerings and ensuring that they meet the necessary legal and safety requirements. You will collaborate closely with various departments, including product development, quality assurance, and marketing, to facilitate the regulatory approval process and ensure timely market access for our innovative healthcare solutions.

Key facts

What you'll do

• Prepare and submit regulatory documentation to local and international health authorities to secure product approvals and maintain compliance.
• Monitor changes in regulatory requirements and guidelines, ensuring that the company remains compliant with all applicable laws.
• Collaborate with cross-functional teams to develop and implement regulatory strategies for new product launches and existing product modifications.
• Conduct thorough reviews of product labeling, advertising, and promotional materials to ensure compliance with regulatory standards.
• Assist in the preparation and management of regulatory submissions, including pre-market notifications and registration dossiers.
• Liaise with regulatory agencies during audits and inspections, providing necessary documentation and information as required.
• Develop and maintain regulatory databases and tracking systems to monitor the status of submissions and approvals.
• Provide training and guidance to internal teams on regulatory requirements and best practices to foster a culture of compliance.
• Participate in risk assessments and develop mitigation strategies to address potential regulatory challenges.
• Stay informed about industry trends and best practices in regulatory affairs to enhance the company's compliance framework.
• Prepare and present regulatory updates and reports to senior management, highlighting key issues and recommendations.
• Support post-market surveillance activities by monitoring product performance and reporting adverse events to regulatory authorities.

Requirements

• Bachelor's degree in life sciences, pharmacy, or a related field; advanced degree preferred.
• A minimum of 3 years of experience in regulatory affairs within the healthcare or pharmaceutical industry.
• Strong knowledge of local and international regulatory requirements, including FDA and CE marking processes.
• Proven experience in preparing and submitting regulatory documents and managing the approval process.
• Excellent analytical skills with the ability to interpret complex regulations and guidelines.
• Strong communication skills, both written and verbal, with the ability to convey regulatory information clearly to diverse audiences.
• Detail-oriented with strong organizational skills to manage multiple projects and deadlines effectively.
• Ability to work collaboratively in a team environment while also being self-motivated and proactive.

Nice to have

• Experience with clinical trial applications and post-market surveillance activities.
• Familiarity with quality management systems and ISO standards relevant to healthcare products.
• Previous experience working with international regulatory agencies is a plus.
• Knowledge of electronic submission systems and regulatory databases.

Skills & tools

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) for documentation and presentations.
• Familiarity with regulatory submission software and databases.
• Strong project management skills to oversee regulatory timelines and deliverables.
• Ability to conduct research and stay updated on regulatory changes and industry developments.

Practical notes

• This position is based in Taguig City, Metro Manila, and may require occasional travel for regulatory meetings or inspections.
• Candidates must be eligible to work in the Philippines, with visa sponsorship available for qualified international applicants.
• The salary for this role is competitive and will be determined based on the candidate's experience and qualifications.
• Interested applicants can apply through the Getzhealthcare career portal at the provided URL.

Join Getzhealthcare as a Regulatory Affairs Officer and contribute to our mission of delivering high-quality healthcare solutions that improve patient outcomes. Your expertise will be crucial in navigating the complex regulatory landscape, ensuring that our products are safe, effective, and compliant with all necessary regulations. We look forward to your application!