Regulatory Affairs Associate Director

**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.
- 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.

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