Assoc. Dir., Regulatory Affairs

Job Description

Associate Director, Regulatory Submissions Archive Operations

 

Location: San Jose, Costa Rica; Prague, Czech Republic (Hybrid role - onsite 3 days per week required)

 

Functional Area: Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS)

 

The Associate Director of Regulatory Submissions Archive Operations supports the Business System Owner (BSO) for the Veeva RIM Submissions Archive and is also responsible for managing the physical paper archives for GRACS. This dual role ensures seamless integration and governance of both digital and physical regulatory records, supporting audits, inspections, litigation, and business transactions.

 

Specific responsibilities of this position include:

• Digital Archive Support (Veeva RIM Submissions Archive)

• • Support the BSO for the Veeva Vault RIM Submissions Archive, providing support to system development, maintenance, enhancements, and monitoring.

  • Liaise with IT, Learning & Development, and global stakeholders to define and implement user requirements, workflows, and metadata standards.

  • Ensure compliance with global regulatory standards and internal SOPs for electronic submissions and correspondence

  • Collaborate with publishing, registration, and planning teams to maintain alignment across the regulatory lifecycle.

• Electronic and Paper Archive Management

• • Oversee the central archive team, including offshore contractors and temporary onshore staff.

  • Manage archival activities related to acquisitions, divestitures, audits, litigation, and regulatory inquiries.

  • Ensure accuracy, throughput, and quality of archival work, including budget oversight for temporary staffing.

  • Coordinate with Business Development Execution teams and system owners of related platforms (e.g., eTMF) for migration and record alignment.

• Strategic Leadership

• • Support GRACS’ long-term strategy to unify regulatory platforms under Veeva RIM, ensuring cross-functional coordination and system interoperability.

  • Represent the archive function in strategic planning meetings, system integration workshops, and change management initiatives.

  • Advocate for continuous improvement in archival processes, leveraging analytics and stakeholder feedback.

Required:

·       Bachelor’s degree in a business, scientific, or operational discipline relevant to the life sciences and/or operations areas or a minimum of 12+ years of industry experience, at least 6 of those in a regulatory/compliance industry utilizing records/document management systems. 

• Direct experience in Veeva RIM Submissions Archive.

• Proven leadership in managing both digital systems and physical archives.

• Strong understanding of regulatory submission types (eCTD, IND, NDA, ANDA) and Health Authority requirements.

• Knowledge of system development lifecycle, data/content administration concepts, and capabilities applying technology within a business environment. 

• Experience supporting and working with tools and systems used in a regulatory/compliance environment, including managing archival collection or distribution for acquisitions, divestitures, litigations, audits, regulatory inquiries, and ad hoc work. 

• Deep knowledge of managing records related to submissions content, health authority correspondences, and other regulatory documents. 

• Demonstrated capabilities managing and mentoring staff, including managing onshore and offshore vendors for records management and related activities. 

• Proven leadership in Change Management with an ability to lead and influence others outside of a direct reporting relationship. 

• Demonstrated collaborative skills and ability to work in cross-functional and international environments. 

• Excellent communication, stakeholder engagement, and project management skills.

• Advanced English skills

Preferred:

• Experience with other modules in Veeva RIM, such as Registrations, Submissions and Publishing.

• Advanced knowledge and capabilities applying technology within a business environment

• Sigma Black Belt, Change Management Certification, PMI Certification.

 

Required Skills:

Accountability, Accountability, Adaptability, Biological Sciences, Business Strategies, Business Systems, Change Management, Cross-Cultural Awareness, Data Management, Divestitures, Document Management, Employee Training Programs, FDA Regulations, Life Science, Mentorship, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Documents, Regulatory Labeling, Regulatory Operations, Regulatory Submissions {+ 4 more}

Preferred Skills:

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Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/10/2026

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