Assoc Director - Publishing

Novo Nordisk A/S; Bengaluru; Sur place; INR 3 500 000 - 6 000 000; Plein temps

Résumé du poste

Novo Nordisk in Bengaluru, India, seeks an Associate Director, Publishing, to lead global publishing activities and own eCTD submission structure with health authorities. You will guide the team, ensure quality and compliance, and drive strategic direction in regulatory publishing.

You will collaborate across Regulatory Affairs, R&D, Global Safety and IT vendors, represent Novo in industry fora, and shape eCTD standards globally while building a high-performance publishing function.

Qualifications

• Master's degree with 6–8 years of relevant experience, including at least 3 years in leadership.
• Deep knowledge of drug development processes and GxP regulatory guidelines.
• Strong eCTD expertise and familiarity with EMA, FDA and PMDA submission requirements.
• Excellent communication and stakeholder management skills.

Responsabilités

• Lead and develop the publishing team and align with Novo's strategic direction.
• Own quality, compliance and QMS for the publishing team.
• Manage complex stakeholder relationships across Regulatory Affairs, R&D, Global Safety, QA, and external authorities.
• Represent Novo in industry fora and contribute to eCTD standards.

Connaissances

Leadership

Regulatory publishing

eCTD expertise

Stakeholder management

Strategic thinking

Formation

Master's degree

Outils

eCTD

Veeva

Regulatory guidelines familiarity

Description du poste

Category: Reg Affairs & Safety Pharmacovigilance

Location: Bangalore, Karnataka, IN

Company – Novo, Global Business Services

Shape how Novo brings life-changing medicines to patients worldwide – by leading the team that ensures every regulatory submission meets the highest standards of quality and compliance.

Your new role

As Associate Director in Publishing, you will lead a team responsible for global publishing activities. You will hold Novo's eCTD expertise and have decision authority over submission structure for health authorities. You will be leading the area in accordance with the area strategy and company transformation.

Your key responsibilities will include:

• Leading and developing your team in line with the Novo Way – clarifying direction, coaching talent, coordinating priorities and ensuring optimal resource utilisation across publishing deliverables
• Driving business performance by setting clear targets, optimising team output and maintaining focus on key deliverables within deadlines
• Owning quality, compliance and environmental management for the team – establishing and maintaining the local QMS in compliance with the Novo Quality Manual
• Managing complex stakeholder relationships across Regulatory Affairs, Clinical Reporting, R&D, Global Safety, QA, DD&IT and senior management, as well as external health authorities, industry peers and IT vendors
• Working in the leadership team in making clear strategic direction for the area
• Representing Novo in industry fora such as the EFPIA eCTD subgroup, Veeva eCTD community and RegOps Symposium – contributing to the evolution of eCTD standards globally

Your new department

In Research & Development, you'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs.

Within R&D, the Publishing department sits in Regulatory, Quality & Clinical Reporting Operations (RQ&C Ops). The team is responsible for ensuring that Novo's regulatory submissions are structured, compliant and delivered to the highest standard across all eCTD countries globally – including Europe, the US, Japan and China. You will lead a team that plays a critical role in getting medicines approved and into the hands of patients.

Your skills & qualifications

We're looking for an experienced leader who thrives in a complex stakeholder environment and brings deep expertise in publishing. You'll bring with you:

• A Master's degree with a minimum of 6–8 years of relevant experience, including at least 3 years of leadership experience
• Expert knowledge of drug development processes and profound understanding of GxP and regulatory guidelines
• Strong eCTD expertise and familiarity with submission requirements across major health authorities (EMA, FDA, PMDA)
• Excellent communication and stakeholder management skills – with the ability to influence and align senior management, cross-functional teams and external parties
• Personal resilience and strategic thinking – you challenge the status quo, make tough decisions for the greater good and remain calm under pressure
• A collaborative leadership style that inspires, develops others and drives high performance without compromising integrity

Working at Novo

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Deadline

16 Oct 2026.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.