What are the responsibilities and job description for the Associate Director, Regulatory Information and Records Management position at Atlas Venture?

Associate Director, Regulatory Information and Records Management

Company Address : 890 Winter Street Suite 220, Waltham, MA 02451

About Kailera Therapeutics

Kailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity and related conditions.

Job Description

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.

We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do :

The Associate Director, Regulatory Information and Records Management role strategically manages all regulatory documentation and data records from third parties, integrating them into broader information management strategies to enhance data governance. This includes the full document lifecycle : translation management, metadata enrichment, standardized naming, and secure archival within Veeva RIM. This role ensures compliance with global health authority expectations, maintains document traceability for audits and inspections, and ensures accurate integration into regulatory submissions.

The ideal candidate has demonstrated experience managing and tracking documents to / from partners (including translations), ensuring accuracy and GxP compliance. Prior experience supporting regulatory records and submissions migration is essential. This individual will support the Head of Regulatory Operations in developing and implementing best-in-class processes and data governance frameworks for efficient document retrieval, data integrity, and optimized Veeva RIM utilization. This involves establishing robust associations between documents and related data within the system to support regulatory intelligence, reporting, and inspections. The role includes actively managing translation consultants / vendors, including performance evaluation and cost-saving identification.

Preferred location : Waltham, MA or San Diego, CA (onsite or hybrid 2-3 days per week).

Responsibilities :

Lead the development and implementation of a comprehensive document metadata strategy, liaising with business partners and internal stakeholders to establish and maintain consistent naming conventions and metadata standards for data integrity and efficient retrieval.

Serve as the primary Regulatory Information Management point-of-contact, engaging cross-functionally with Regulatory Affairs, Clinical, CMC, Quality, and IT teams to proactively identify and manage translation requirements and ensure alignment between document governance frameworks and global submission strategies.

Collaborate with departments to identify documents requiring translation.

Eliminate duplicate document entries imported from partners or created internally.

Manage the translation vendor relationship, implementing structured performance evaluations to assess translation quality, efficiency, and cost-effectiveness.

Ensure translations undergo rigorous QC for linguistic consistency and regulatory terminology alignment.

Lead the development and reporting of KPIs related to translation timelines, costs, and quality.

Create corresponding document data records in Veeva RIM (submissions, health authority questions, commitment records) related to third-party / partner documents.

Manage the migration of translation documents, certificates, and source files into Veeva RIM.

Develop and implement procedures for managing and archiving third-party (CRO) submissions and approval records within Veeva RIM, ensuring compliance.

Oversee processing and archival of documents received via Email to RIM and the RIM-eTMF connector.

Ensure effective management of regulatory commitments : manage entry and follow up with owners to confirm status through close-out, ensuring traceability and compliance.

Conduct regular audits and quality checks on documents and data received through the eTMF-RIM connector; interact with eTMF administrators to address issues.

Provide ad hoc support for regulatory submissions (content tracking and publishing).

Required Qualifications :

Minimum of 8 years industry experience in document lifecycle management within regulatory affairs

Extensive experience in regulatory document control, records management governance, and industry best practices and standards.

Detail oriented with excellent prioritization and organizational skills

Experience in developing and implementing processes is required.

Clear understanding of drug development, including phases, processes, and techniques used within clinical development

Demonstrated ability to effectively communicate both in written communications and through presentations and facilitation

Ability to work both independently and as part of cross-functional team

Proficiency with relevant software applications, including Veeva RIM, Veeva eTMF, SharePoint, Egnyte, etc.

Emotional intelligence – demonstrate the ability to manage through stressful situations ensuring a win-win approach

Veeva Vault RIM Administrator experience required

Education :

Benefits of Working at Kailera

In addition to traditional benefits, we provide enhanced offerings designed to support the well-being and financial security of our team members and their families.

Comprehensive health benefits and tax-advantaged savings accounts

Flexible time off, 13 paid holidays, and a companywide year-end shutdown

Monthly wellness stipend

Generous 401(k) match

Disability and life insurance

At Kailera, we are committed to fostering an inclusive culture. How we treat our people is reflective of this commitment. We share the pay range for this particular role with the actual base salary depending upon factors such as job-related knowledge, skills, market factors, and experience.

Salary Range : $160,000 - $200,000 USD

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Salary : $160,000 - $200,000

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Associate Director, Regulatory Information and Records Management

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