Pharma Product Manager - Connected Regulatory Intelligence

Pharma Product Manager - Connected Regulatory Intelligence

The IQVIA Connected Regulatory Intelligence (CRI) is a groundbreaking innovative solution that simplifies, integrates, and automates end-to-end regulatory processes that are essential for industry clients in meeting their global quality, regulatory and safety compliance obligations. The CRI solution leverages IQVIA's unique regulatory intelligence platform to allow users to seamlessly query IQVIA's intelligence as well as their own organization's insights and Health Authority Interactions (HAI) to improve and accelerate quality, regulatory and safety activities such as strategic planning, submission management and publishing work amongst others.

About the role

• The individual will take a key role in supporting the Product Lead in defining and aligning stakeholders around the product vision for the Pharma segment.
• This role is responsible for understanding, documenting, and representing the Pharma user needs for the suite of regulatory applications
• In this role the individual will provide input into the prioritization of product features and capabilities.
• The individual will be supported by one Business Analyst. It is the Product Manager's responsibility to oversee and support the business analyst in the timely completion of documentation and other related tasks.
• The role will work on several regulatory software applications that leverage the Connected Regulatory Intelligence Platform.
• The individual fulfilling this role will also help the definition of additional intelligence required in the platform to further drive pharma regulatory process automation.
• This role will involve actively interacting with customers including internal IQVIA regulatory teams to discuss regulatory processes, user experience and software implementation to gather and document user feedback.

Principle Accountabilities:

To Accomplish this role, the candidate will apply their experience of regulatory affairs and the knowledge of current regulatory requirements across the globe to:

• Define the regulatory business requirements for the software applications
• Translate the business requirements into technical documentation
• Support the prioritization of features and functionalities for pharma customers
• Create high-level solution concept diagrams that detail how to solve the problem
• Facilitate brainstorming, visual collaboration and diagramming sessions between all the stakeholders, knowledge matter experts and engineering teams
• Successfully complete technical documentation and support the development and QC activities across the development lifecycle
• Continuously monitor and update new, revised, or emerging global regulatory requirements as required by the business
• Mentor, coach and share subject matter expertise with others to elevate our capabilities to deliver world-class solutions for clients.
• Manage and support the Pharma business analyst

Experience and Skills Required:

• Qualifications in engineering, life sciences or related discipline
• In-depth understanding of global and country specific regulatory requirements across multiple regulatory activities such as MAAs, MATs, CMC, variations, etc.
• Possesses at least 8 years of relevant regulatory affairs experience and/or technical expertise preferably in preparing application dossiers and agency interactions
• Experience of gathering and maintaining regulatory intelligence will be an advantage
• Knowledge and experience using software systems developed for regulatory, safety, clinical and quality (validated systems) will be an advantage
• Ability to become the liaison between the business and the technical development teams
• Demonstrated ability to manage and drive project contributions in a timely manner
• Ability to create strong working relationships across the organization: collaborating with cross-functional teams including technology, regulatory, quality, clinical affairs, and others

• Strong communicator that can coach and manage a small team
• Strong analytical, organizational, and problem-solving skills
• Self-motivated and enthusiastic

The opportunity:

You will be working on a groundbreaking innovative solution and directly impacting patient health through transforming client operations that bring safe and effective medical product to global markets in optimized timelines.

We are a diverse, global team that shares a passion for collaboration and solving problems using best functional expertise and most advanced technologies to transform how regulatory teams do their daily jobs. Together, we will make a difference.

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