Regulatory Affairs Associate Manager

2 weeks ago

Petaling Jaya, Malaysia Merck KGaA Full time

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans '“ so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**What You Do**
- Support in the regulatory affairs strategy and submission of biopharmaceutical and medical devices in Malaysia.
- Coordinate with the APAC Regulatory Hub of regulatory tasks and assist in the update, enhancement & creation of internal procedures.
- Interpret, communicate regulatory expectations, develop strategies and risk assessments to internal & external stakeholders in order to execute and achieve submission timelines in compliance with applicable regulations.
- Manage all communications with the Health Authorities.
- Support country & commercial strategy with insights from regulatory intelligence.
- Manage relationships & have fluent communication with third parties, cross-functional stakeholders & other partners to attain performance & identify or solve problems that arise & are critical within the submission processes.
- Participate in business meetings with cross-functional teams & external customers and provides active and ongoing guidance within submission projects.
- Review and release of promotional materials according to local regulations and corporate policies, as needed.
- Review and release of artworks according to local regulations and corporate policies, as needed.
- Active participation in regulatory associations.
- Conduct trainings to enhance teams’ knowledge of working in a regulated environment. Support other activities as per business need.

**Who You Are**
- Bachelor's degree holder with more than 5 years regulatory experience
- Know-how in Malaysia regulatory requirements for pharmaceutical products and medical devices.
- Excellent English and Malay verbal and written communications skills
- Ability to interact effectively with all levels of management.
- Effective time management skills to multi-task several initiatives with demonstrated ability to achieve success.

The position will report to APAC RA Hub Regional Regulatory Affairs Manager.

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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