Regulatory Affairs Project Manager
5 days ago
Madrid
Taketalent is partnering with PharmaMar, a leading biopharmaceutical company dedicated to the research, development, and production of innovative oncology therapies, to find a Regulatory Affairs Project Manager with an international scope. This is a hybrid position, ideal for professionals eager to manage strategic regulatory projects globally and contribute to the success of end-to-end innovative products. The selected candidate will play a key role in managing regulatory submissions, global regulatory strategies, and cross-functional coordination, ensuring that projects meet the highest scientific and regulatory standards. This position has significant impact on the company and the international trajectory of PharmaMar’s oncology R&D programs. Key Responsibilities: • Develop and maintain international regulatory submission plans (MAA/NDAs, CTAs, INDs, variations, Orphan Drug Applications, Pediatric Investigational Plans, Scientific Advice Requests, etc.)., • Coordinate regulatory activities with internal departments: Clinical Development, Medical Affairs, Pharmacovigilance, Quality, Manufacturing & Supply, Legal, Business Development, and Commercial., • Contribute to defining global regulatory strategies, identifying risks and opportunities., • Lead complex regulatory applications, including interactions with international authorities and external experts., • Review clinical and scientific documentation to ensure regulatory compliance., • Manage regulatory databases and collaborate on international regulatory strategies., • Supervise CROs and work effectively with global project teams. Requirements: • Degree in Health Sciences (PhD, MSc, or MBA preferred)., • Fluent in English, both written and spoken., • Industry experience: at least 3 years in Regulatory Affairs and Project Management within the biopharmaceutical sector., • Management of regulatory deliverables at the project level, • Thorough knowledge of the drug development process, • Knowledge of Business and processes in the pharmaceutical industry, • Knowledge of clinical development, ideally oncology., • Experience with electronic submission techniques-working on e-CTD, • Highly Valued: Global knowledge in CMC, preclinical, and clinical development, • International regulatory experience is an advantage, including interactions with authorities across multiple markets. What We Offer: • Competitive salary + performance-based bonus., • Benefits package (private health insurance, stock plan, continuous training, company cafeteria, etc.)., • Flexible working hours with short Fridays., • Opportunity to contribute to a leading oncology company with global impact., • Commitment to diversity, equal opportunities, and an inclusive work environment. If you meet the requirements and are looking for a professional challenge in regulatory affairs with international scope, we would be delighted to receive your application.
Roberto G.Active 2 days ago
