What are the responsibilities and job description for the Associate Director, Regulatory Information and Records Management position at Kailera Therapeutics, Inc.?
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 :
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.
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
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION :
Kailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
E-Verify :
Kailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.
LI-Hybrid
Salary : $160,000 - $200,000
