O-216 - SENIOR REGULATORY COMPLIANCE SPECIALIST

Bebeeregulatory


Job Description The Regulatory Affairs Senior Associate will provide regulatory support for the portfolio, encompassing both innovation projects and maintenance of defined records, adhering to internal guidelines and applicable regulations. This role is responsible for ensuring that products within their scope can be commercialized in the market with optimal compliance aligned with business plans and interests. Additionally, they will guarantee that the product portfolio maintains and meets internal and external requirements. Main Responsibilities: - Ensure products within their area of responsibility can be marketed with excellent compliance in line with business plans and interests. - Maintain and ensure the product portfolio complies with internal and external requirements. - Act as a responsible voice for the organization in front of local regulators, industry associations, trade associations, and other external regulatory bodies. - Be a productive and effective partner of the local regulatory team and an ally to other interested areas (MKT, Sales, Supply, etc.). - Provide solid and applicable information on regulatory innovation strategies and portfolio maintenance, as well as process improvement/compliance activities within the defined scope. Required Skills and Qualifications To succeed in this role, you should have: - A degree in Pharmaceutical Chemistry or related disciplines. - 5+ years of experience in Regulatory Affairs for Pharmaceuticals, Medical Devices, and Cosmetics, in the pharmaceutical and consumer industries, and all related healthcare topics. - Advanced English language skills. - Teamwork abilities. - Customer and results-oriented approach. - Open dialogue and negotiation skills. - Knowledge of legislation, technical, and legal aspects. - Project management knowledge. Benefits We offer a dynamic work environment that values diversity and inclusion. At our organization, we strive to create a workplace where everyone feels welcome and valued. We believe in flexibility and offer an agile working culture for all roles. As an equal opportunities employer, we are committed to creating an inclusive environment where everyone has an equal chance to thrive. We do not discriminate based on race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, or any other protected class. Accommodations If you require reasonable accommodations or need assistance during the application process, please let us know by providing a description of your specific needs. We will provide all necessary accommodations to support you throughout the recruitment process and keep all information confidential.

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