Senior Director - Business Transformation Regulatory (Hybrid/Remote)

Job Overview:

The Pharma Strategy Lead will be the spearheading the partnership between the innovative and passionate group of IQVIA and several pharmaceutical customers that are pursuing innovation for the regulatory affairs function.

The IQVIA team is driven by the mission of transforming industry Quality, Regulatory affairs and Safety processes, to improve the day-to-day work of quality, regulatory and safety teams and accelerate the time to product approval and access to new therapies for patients. As part of the CRI team, you will be a key contributor to the development of strategic perspectives on how the regulatory affairs function can be transformed utilizing connected intelligence in conjunction with state-of-the-art technology, simplification, and automation practices.

Principle Accountabilities:

• Uses extensive knowledge and experience in regulatory affairs to define approaches to apply connected intelligence, technology, and process engineering to simplify, automate and integrate quality, regulatory and safety processes to deliver strategic and operational improvements in conjunction with industry players.
• Representing the IQVIA Connected Intelligence team in discussions with clients and building relationships with regulators and other key stakeholders.
• Providing and facilitating an expert-level interface between regulatory agencies and client when required.
• Act as a key regulatory affairs expert, providing internally and externally expertise on regulatory strategy, process, systems, best practices.
• Acting as a regulatory strategy lead working with cross-functional teams to contribute to the development of intelligent workflow applications.
• Provide senior-level strategic direction and support to the business development team demonstrating the value of IQVIA solutions to clients.
• Provide senior-level strategic direction and oversight to the implementation teams on client delivery.
• Engage in and execute thought leadership initiatives supporting and showcasing connected regulatory intelligence solutions and the wider organization, for example with other Regulatory strategists to review how the CRI team can best deliver a solution that works for Pharmaceutical, MedTech and Cross Border products..
• Provide strategic and operational leadership for promotional and educational communications.

Experience and Skills Required:

• At least 15 years of experience with regulatory affairs, regulatory strategy, regulatory intelligence, and regulatory operations in the pharmaceutical industry with a demonstrable record of career advancement accomplishments.
• With a proven record in deploying successful global regulatory strategies for new product registrations in a variety of geographies and for a variety of product types
• Significant knowledge of regulatory requirements across the full product lifecycle with a proven track record for successful negotiations with health authorities.
• Ability to manage multiple projects, co-ordinate with SMEs and lead discussions with clients.
• Demonstrated understanding of regulatory requirements across multiple pharmaceutical product types, e.g., small molecules, biologics, and vaccines.
• Advanced degree (PhD, PharmD, MD, MS) in a science related field (Chemistry, Cellular or Molecular Biology, Pharmaceutics or Process Engineering) or similar preferred, although emphasis is on experience.
• Excellent communication and interpersonal skills and a track record of working effectively in matrixed teams.
• Good technology and data management understanding enabling successful interaction with product management and data curation teams.
• Experience as a consultant will be an advantage.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA's ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status