Director Structured Content Authoring- Regulatory Affairs

The Director, Structured Content Authoring is a transformational leadership role responsible for accelerating the organisation's evolution from document-centric regulatory operations to a modern, data-driven and component-based operating model. This leader will establish the vision, strategy and governance framework that connects structured regulatory content, medicinal product master data and enterprise data governance to create authoritative, reusable and traceable information assets that support global regulatory compliance, operational excellence and future digital health requirements.

The role will lead the development of an integrated enterprise capability spanning Structured Content Authoring, IDMP data governance, regulatory master data, controlled terminology, metadata management and information architecture.

Working across Regulatory Affairs, Regulatory Data Management, Labelling, CMC, Clinical, Safety, Quality, Manufacturing, Supply Chain, Technology and Data organisations, you will align senior stakeholders around a common strategy, operating model and investment roadmap that enables consistent, interoperable and high-quality regulatory content and data.

What you will do:

• A key area of responsibility will be establishing governance structures, ownership models, decision rights, quality standards and stewardship practices across regulatory content and data domains.
• Oversee reusable content components and data assets covering labelling, CMC, clinical and submission content, ensuring information can be efficiently created, approved, maintained, reused and traced throughout the product lifecycle.
• Provide strategic leadership for IDMP governance, including product, substance, organisation, referential, registration, manufacturing and packaging data, ensuring alignment with global regulatory standards and evolving agency requirements.
• In partnership with Regulatory Technology, enterprise architecture and data engineering teams, you will shape the future-state architecture connecting RIM platforms, structured content solutions, master data management, terminology services, publishing platforms, analytics and AI-enabled capabilities.
• Ensure that automation, AI and advanced regulatory technologies are grounded in trusted, governed and traceable content and data.

What you will need:

• The ideal candidate will bring substantial experience of relevant life sciences experience and a proven track record of regulatory data governance, IDMP, RIM platforms, master data management, information architecture and digital transformation.
• A strong understanding of global regulatory standards, including ISO IDMP, XEVMPD/Article 57 and EMA SPOR, is highly desirable.
• Experience with Veeva Vault RIM, Structured Content Authoring platforms, data catalogues, knowledge graphs, FHIR, automation technologies and participation in industry standards forums would be advantageous.
• Experience in establishing governance frameworks, operating models, ownership structures and data standards that support regulatory compliance, data quality, content reuse and operational excellence.
• Strong strategic leadership, executive communication and stakeholder management capabilities, with the ability to influence across organisational boundaries and build alignment within complex, cross-functional environments.

Required Skills:

• Collaborative Leadership
• Detail-Oriented
• Operations Support
• Process Improvements
• Regulatory Compliance
• Regulatory Experience
• Regulatory Processes

Employee Status: Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements: Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA

Job Posting End Date: 10/12/2026 A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.