Abbott - Manager - Regulatory Affairs - Submission Publishing

Job role: Manager Publishing

Job Summary:

We are seeking an experienced and proactive leader to head our Submission Publishing team. The ideal candidate will be responsible for delivering high-quality regulatory submissions while ensuring compliance with global health authority requirements. This role involves managing a high-performing team, optimizing processes, troubleshooting technical issues, and collaborating with cross-functional stakeholders to drive operational excellence.

Key Responsibilities:

Team Leadership & Operations

- Lead and mentor a high-performing team of submission publishers.

- Manage workload vs. resource allocation to ensure optimal team productivity and efficiency.

- Oversee the publishing workflow to ensure timely and compliant submission delivery.

- Conduct regular performance evaluations and support career development plans.

- Lead hiring and onboarding of new talent.

Regulatory Submission Management

- Ensure submission quality by resolving publishing challenges and guiding the team in troubleshooting.

- Drive a First-Time-Right approach by educating the team and upstream workstreams on regulatory and publishing requirements.

- Monitor regulatory requirements across regions and ensure team adaptation and compliance.

- Actively participate in testing and documenting new tool upgrades or implementations.

Cross-functional Collaboration & Stakeholder Management

- Collaborate with Regulatory Affairs, Affiliates, and Regional Leads to resolve submission gaps and drive alignment.

- Participate in eCTD kick-off meetings and contribute to discussions around implementation in new markets.

- Optimize cost by identifying user-related errors before raising IT support tickets.

- Work closely with tool vendors (e.g., ArisG) to address technical publishing tool-related queries and contribute to feature development.

Training & Development

- Conduct Train-the-Trainer programs and ensure end-user training for publishing systems.

- Serve as Subject Matter Expert (SME) across pharma and vaccine product lines.

- Develop simplified SOPs and process documentation for team reference.

- Build team competencies through regular knowledge sharing and capability-building sessions.

Technical Competencies & Expertise:

- Strong expertise in eCTD concepts, publishing standards, and troubleshooting.

- Hands-on experience with publishing tools; ability to identify white spaces and suggest improvements.

- Understanding of regional regulatory requirements especially RoW (EM), EU, and US markets.

- Proven experience in Regulatory Operations, including both technical and strategic aspects.

- Demonstrated ability to drive process improvements and efficiency initiatives.

Qualifications & Experience:

- Bachelor's/Masters degree

- 1012 years of experience in Regulatory Affairs or Submission Publishing.

- Minimum 56 years of experience in managing teams and leading regulatory operations.

- Strong interpersonal, communication