Regulatory Affairs, Quality and Pharmacovigilance Manager
Oborishte Region, BG, 1517
At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, ACO®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
Join us on our One Perrigo journey as we evolve to a blended-branded business to win in self-care.
Description Overview
Regulatory Affairs, Quality and Pharmacovigilance Manager will be responsible for managing the RQS affiliate team and supervising external consultants. In this role you will be managing licensing and post marketing activities for assigned Perrigo brands. You will also be working with multiple functions and external stakeholders (including authorities) across different product categories (medicinal products, cosmetics, food supplements, medical devices, biocides) in the following countries: Bulgaria, Slovenia, Croatia, Bosnia, Serbia.
The role will be located at Perrigo Bulgaria 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 within Bulgaria, Slovenia, Croatia, Bosnia, Serbia.
- Ensuring strategies and relationships with internal (e.g. GPS, CQA, Global Supply, CSCI Marketing, Commercial) and external stakeholders (e.g. competent authorities in Bulgaria, Slovenia, Croatia, Bosnia, Serbia, external consultants).
- Ensures company’s regulatory affairs activities are conducted according to relevant regulations, laws, and standards in the region.
- Oversees and support quality assurance and 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 region.
- Being accountable for the RA budget planning and monitoring within the region.
Experience Required
- Minimum 7 years’ experience from the pharmaceutical/life science/selfcare industry, with a focus on regulatory affairs and a profound understanding of quality assurance and pharmacovigilance as applying to OTC/ self-care products.
- Must have leadership experiences and change management skills.
- Ability to manage a regional team and direct reports in a hybrid model (on-site and remote.)
- Must have experience from launching new self-care products and interactions with external stake holders.
- Ability to manage cross-functional projects efficiently.
- Proactive and results-oriented: takes ownership, can work independently, has a can-do attitude
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 Total Rewards 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 here
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