[Qzt54] - Regulatory Affairs Associate Director

hace 4 días

Madrid, España Mcr International A tiempo completo

LAR-2411-365 REGULATORY AFFAIRS ASSOCIATE DIRECTOR MADRID Regulatory Affairs Associate Director Opportunity – Join a Leading Pharmaceutical Company in Madrid, Spain

At MCR International, we're thrilled to announce an exclusive opportunity for a Regulatory Affairs Associate Director with a renowned 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.

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