Company Description
Schülke & Mayr, founded in 1889, is a global leader in hygiene, infection prevention, and treatment, offering over 300 innovative products worldwide. With renowned brands like octenisept®, mikrozid®, and desmanol®, the company delivers solutions across Healthcare, Life Sciences, Over-the-Counter (OTC), and Direct Patient Care business fields. Headquartered in Germany, Schülke & Mayr has a strong global presence, selling products in over 100 countries through 20 subsidiaries and production facilities in Germany, France, and Brazil. With a workforce of over 1,200 dedicated employees, our focus remains on pioneering quality and innovative solutions in the chemical and pharmaceutical industries.
Role Description
This is a full-time, on-site role based in Singapore for a Regulatory Affairs Manager. The role involves overseeing regulatory compliance processes, preparing and submitting regulatory submissions, and ensuring that all operations meet current regulatory requirements. The manager will collaborate with cross-functional teams to maintain and improve quality systems, support audits, and ensure timely updates of regulatory policies and documentation. Responsibilities also include tracking changes in regulations, coordinating with international regulatory authorities, and providing guidance on regulatory strategies to ensure compliance in all relevant markets.
Key Responsibilities:
- Manage regulatory affairs for the organization across assigned territories, including new product registrations, product notifications, product variation applications, and transfer of product licenses.
- Obtain timely renewal of product licenses and maintain an up-to-date registration database.
- Ensure appropriate licensing, regulatory, marketing, and legal compliance of products in each country, supported by local regulatory and distribution partners.
- Liaise with regulatory authorities and distribution partners in the region to maintain product licenses and enable ongoing sales activities.
- Ensure product labels and associated materials are compliant with relevant regulatory requirements for each market.
- Collaborate with the Global and Regional Regulatory Affairs team, communicate actively across internal departments, and coordinate with distributors and regulatory consultants to achieve timely application submissions.
- Provide training on regulatory and quality topics as required.
- Ensure compliance with local government requirements and assume responsibility for QMS maintenance and updates, including adherence to Good Distribution Practices for medical devices.
- Support quality review and batch test reports, ensuring products meet the necessary standards for quality release.
- Support internal audits across the organization's entities and manage external audits with warehouse partners and manufacturing suppliers.
- Support outsourcing projects involving technology transfers, quality audits, and dossier preparation, working closely with stakeholders in quality and regulatory departments and adapting to local requirements.
- Develop and execute regulatory strategies for new products and any changes within target markets.
Qualifications
- Experience with Regulatory Compliance, ensuring adherence to local and international regulations.
- Knowledge of Regulatory Requirements and affairs, with the ability to navigate complex regulatory frameworks.
- Proficient in handling Regulatory Submissions, including preparation and tracking of documentation.
- Understanding of Quality Systems and their role in regulatory compliance.
- Strong analytical, organizational, and communication skills.
- Bachelor's degree in a relevant field such as Pharmacy, Life Sciences, or Chemistry.
- Experience in the pharmaceutical, chemical, or healthcare industries preferred.
- Knowledge of regulatory frameworks in Asia-Pacific regions is an added advantage.
