Regulatory & Safety Project Manager

Description Overview

The Regulatory Affairs & Safety Project Manager will be responsible for managing the RQS affiliate team and supervising an external consultant responsible for quality.

You will be managing licensing and post marketing activities for assigned Omega Pharma / Perrigo brands (among others : Coldrex, Niquitin, Paranit, Compeed, Ella One, etc).

You will work with multiple functions and external stakeholders (including authorities) across different product categories (medicinal products, cosmetics, food supplements, medical devices, biocides) in Hungary.

The role will be located at Omega Pharma Hungary and will be reporting to head of Regulatory, Quality, Safety Central Easter Europe.

Scope of the Role

• Oversight for regulatory licencing and post marketing regulatory activities for all products registered and actively marketed in Hungary.
• Ensuring strategies and relationships with internal stakeholders (e.g. Global Patient Safety, Corporate Quality Assurance, Global Supply, Global Marketing, Commercial) and external stakeholders (e.g. competent authorities in Hungary, external consultants).
• Ensures company’s regulatory affairs activities are conducted according to relevant regulations, laws, and standards in the country.
• Oversees and support pharmacovigilance activities in the region to ensure compliance with relevant regulations. Ensure that an QA / PV operating model is maintained according to the business needs in the region.
• Ensure that optimal collaboration and ways of working are established and maintained with Corporate / Global enabling functions
• Ensures appropriate basis for implementation of regional / local marketing strategies are identified and / or implemented; assists in identification of advanced regulatory strategies for regulatory classifications within scope.
• Ensures that right processes and procedures are in place in the country.
• Being accountable for the RA budget planning and monitoring in the country.

Experience Required

Benefits

We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally. Find out more about at Perrigo. Hybrid Working Approach

We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more Applicants please note :  To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities. #DIV #weareperrigo