Global Regulatory Affairs Associate Director

1 week ago

Greater London, United Kingdom Novartis Full time

Job Description Summary #LI-Hybrid (12 days per month on-site) Location: London (The Westworks) United Kingdom or Dublin Ireland Internal Job Title: Global Program Regulatory Associate Director We are looking for an experienced and proactive Senior Global Program Regulatory Manager to join our Global Regulatory Affairs role involves directing the development and submission of regulatory documents providing strategic direction and negotiating with agencies to expedite approvals. It also ensures timely approval and compliance of new and marketed products and serves as a regulatory liaison throughout the product lifecycle. Job Description Major accountabilities Lead the implementation of regulatory strategies and operational activities across major global regions. Provide strategic input into global regulatory plans identifying risks and contributing to key planning documents. Align regional regulatory approaches with global objectives through collaboration with cross-functional and regional teams. Define and manage Health Authority (HA) interaction strategies including preparation of briefing materials. Oversee the planning coordination and submission of regulatory dossiers (e.g. CTAs INDs Risk Management Plans). Serve as a liaison with local HAs (e.g. FDA EMA) and lead or support negotiations for regional approvals. Develop and implement strategies to minimize review delays and regulatory clock stops. Ensure timely and compliant responses to HA queries and requests. Contribute to departmental goal setting and lead initiatives to improve regulatory processes. Ensure adherence to internal policies SOPs and global regulatory requirements. Minimum requirements Bachelors or Masters degree in Life Sciences Pharmacy or a related field. Significant experience in regulatory affairs within the pharmaceutical industry. Proven track record in project management and regulatory operations. Experience representing the organization in cross-functional and cross-cultural settings. Strong knowledge of clinical trials drug development and regulatory compliance. Excellent problem-solving negotiation and communication skills. Detail-oriented with the ability to manage complex regulatory projects. Skilled in risk management and working with cross-functional teams. Ability to navigate and influence Health Authority interactions. Fluency in English (written and spoken) is essential. Commitment to Diversity and Inclusion / EEO Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve. Skills Desired Clinical Trials Cross-Functional Teams Detail-Oriented Drug Development Lifesciences Negotiation Skills Problem Solving Skills Regulatory Compliance Risk Management Required Experience Director Key Skills Proofreading Adobe Acrobat FDA Regulations Manufacturing & Controls Biotechnology Clinical Trials Research & Development GLP cGMP Product Development Chemistry Writing Skills Employment Type: Full-Time Experience: years Vacancy: 1 #J-18808-Ljbffr

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