LAR-2411-365REGULATORY AFFAIRS ASSOCIATE DIRECTORMADRIDRegulatory Affairs Associate Director Opportunity – Join a Leading Pharmaceutical Company in Madrid, Spain!AtMCR International, we're thrilled to announce an exclusive opportunity for aRegulatory Affairs Associate Directorwith arenowned global pharmaceutical company.
This strategic role, based in Madrid, Spain, offers a unique chance to shape and implement groundbreaking regulatory strategies on a global scale, directly aligning with the company's overall business objectives.Role Overview:As the Regulatory Affairs Associate Director, your primary mission will be to develop and execute innovative global regulatory strategies that drive product development and approval across international markets.
This role requires a deep understanding of complex regulatory landscapes and the ability to collaborate effectively with major Health Authorities (US, EU, Japan, and China) to ensure successful compliance and approval.Key Responsibilities:Strategic Leadership: Spearhead the development and execution of integrated global regulatory strategies for assigned projects and products.Global Representation:Act as the company's regulatory representative in communications with regulatory authorities, contractors, and corporate partners.Clinical & Pre-Clinical Guidance: Oversee regulatory strategies related to clinical and pre-clinical product phases, supporting lifecycle management and clinical development planning.Risk Mitigation: Assess and mitigate regulatory risks, providing crucial guidance to internal teams throughout the R&D process.Submission Oversight: Lead global regulatory submission processes, including marketing applications, briefing packages, and CTA submission strategies.Cross-Functional Collaboration: Advise and collaborate with cross-functional teams on global regulatory requirements, ensuring alignment with strategic objectives.Regulatory Insights: Monitor and analyze regulatory agency activities, assess their impact on ongoing programs, and provide timely strategic advice.Mentorship & Development:Mentor and guide Regulatory Project Managers and foster their development within the organization.What We're Looking For:Qualifications:Degree in Life Sciences or a related field is required; an advanced degree (PharmD, MSc, PhD, MBA) is preferred.Experience:Industry Expertise:Minimum of 8 years in the pharmaceutical or biotechnology industry, with at least 6 years in Regulatory Affairs (Strategy).Global Regulatory Knowledge: In-depth understanding of regulatory landscapes in the US, EU, and Japan, with direct experience engaging with regulatory bodies such as FDA, EMA, and PMDA.Submission Experience: Proven track record of preparing and managing major regulatory submissions and amendments.Cross-Cultural Sensitivity: Experience in multinational settings and leading multidisciplinary teams.Key Skills:Leadership & Communication: Exceptional leadership abilities, with strong interpersonal skills for effective collaboration across senior management, scientific, and manufacturing teams.Organizational Excellence: Strong organizational skills to prioritize workloads effectively in a dynamic environment.Strategic Vision:Ability to set direction, influence decision-making, and represent the company in high-stakes regulatory discussions.If you're ready to take on a pivotal role that will shape the future of global regulatory strategy within a highly respected pharmaceutical organization, we invite you to apply.
This is an extraordinary opportunity to lead, innovate, and make a lasting impact on the global healthcare landscape.#J-18808-Ljbffr