Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
A healthier future. It is what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That is what makes us Roche.
Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization compliance with the applicable regulations. Implements processes and systems to ensure that all necessary filings, certifications, and permits are processed and monitored.
Key responsibilities include;
- Contributing to the organization's strategic plan and annual plans, in areas such as quality and risk management, regarding registration matters.
- Reviewing draft registration files and submitting new and amended registration dossiers to obtain and maintain registration.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Communicate regulatory information to multiple departments and ensure that there is an accurate interpretation of the issuance or report.
- Provide regulatory guidance to regulatory affairs team, departments & development project teams regarding design, development, evaluation, or marketing of products.
- Manage activities such as audits, regulatory agency inspections, or product recalls
- Review materials such as marketing literature or user manuals for compliance
- Supports Supply Chain, Marketing and Sales Department by providing regulatory relevant documents and guidance on regulatory requirements.
- Establish regulatory priorities or budgets and allocate resources and workloads
Who you are:
- Bachelor's/Master degree in Pharmaceutical or Science related field (preferably medical laboratory related).
- 3-5 years of experience in regulatory affairs in an IVD/ Medical Devices/ Pharmaceutical Company & 1-3 years supervisory experience desired.
- Extensive knowledge of the function and department process.
- Proficient in both English and Filipino (written & spoken)
- Advance computer skills.
- Excellent organization and time management skills
- Confident in giving presentations and negotiating
- An analytical and problem-solving mindset
- Self-Initiative and Proactive, values continuous improvement
- Critical thinking skills and able to manage complex regulatory issues.
- Good project management skills and able to drive and deliver registration goals
- Able to develop and maintain a good network across multiple levels within the organization as well as externally.
- Able to influence, manage and make sound recommendations to all stakeholders
- Willingness to travel
Be inspired by who we are, what we do and how we do it.
Visit https://www.roche.com/careers.htm to learn more about Roche.
Roche is an equal opportunity employer.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
