IQVIA hiring for Associate Director, Regulatory Affairs

IQVIA hiring for Associate Director, Regulatory Affairs

Associate Director, Regulatory Affairs

📍Bangalore, India

Job Type:
Full-Time
Job Responsibilities:
We are seeking an experienced Labeling COE Lead & Regulatory Intelligence Expert with a minimum of 15 years in regulatory roles and a demonstrated record of effective client engagement, consulting, BDI defense management, and line management. The successful candidate will have a strong understanding of regulatory compliance and a proven ability to manage complex projects and lead cross-functional teams.

Responsibilities:

Lead and manage the Labeling Center of Excellence (COE) and Regulatory Intelligence (COE), setting strategic direction, and ensuring operational efficiency and effectiveness. Act as a subject matter expert in regulatory intelligence, staying abreast of changes and developments in regulations and guidelines, and interpreting their impact on the business. Drive and oversee the creation and management of product labeling, ensuring compliance with regulatory standards. Liaise with regulatory authorities, coordinate responses to regulatory inquiries, and manage regulatory inspections Drive the development and execution of regulatory strategies and plans. Collaborate with cross-functional teams to ensure regulatory compliance and manage risk. Lead client engagements and provide regulatory intelligence consulting to clients, demonstrating exceptional communication and relationship-building skills. Oversee BDI defense management, ensuring robust defense strategies and plans are in place. Drive continuous improvement in regulatory processes and systems, utilizing data and insights to inform decisions.

Qualifications:

Minimum of 15 years of regulatory experience, preferably in a leadership role. Proven experience in client engagement, consulting, BDI defense management, and line management. Deep knowledge of regulatory compliance and labeling requirements. Strong project management skills, with a proven ability to manage complex projects and lead cross-functional teams. Exceptional communication and relationship-building skills. Strong analytical and problem-solving skills. Ability to interpret and apply regulatory intelligence to inform business decisions. Master’s degree in a related field; advanced degree preferred.

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