Manager - Submission Management

Merck Healthcare; Bengaluru; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Merck Healthcare seeks a seasoned submissions leader to shape and run the Submission Management sub-team within Global Regulatory Affairs. You will ensure the highest standards of quality, compliance, and timeliness for regulatory submissions.

You will coach the team, set priorities, and drive continuous improvement while acting as the primary expert for eCTD and submission workflows. You will collaborate with cross-functional partners and guide capabilities to sustain regulatory excellence

Qualifications

• Experience in regulatory publishing and submission management.
• Experience with leading and coaching a team.

Responsibilities

• Lead the Submission Management sub-team within Global Regulatory Affairs, ensuring quality, compliance and timeliness.
• Own day-to-day team performance: set priorities, coach members, drive process improvements in submissions.
• Serve as the primary expert for eCTD and submission management, guiding regulatory challenges and harmonizing activities across functions.

Skills

Regulatory publishing

Submission management

People leadership

eCTD standards

Regulatory information mgmt

Stakeholder communication

Education

Degree in Pharmacy, Life Sciences or related

Tools

Electronic document management systems

Job description

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your Role

In this pivotal role, you will lead and shape the Submission Management sub-team within Global Regulatory Affairs, ensuring that every regulatory submission meets the highest standards of quality, compliance, and timeliness. You will be accountable for the day-to-day performance of your team - setting priorities, coaching team members, and driving continuous improvement across submission processes. As the primary expert for electronic Common Technical Document (eCTD) and submission management, you will guide your team through complex regulatory challenges, harmonize activities across functional areas, and serve as a key point of contact for submission-related expertise.

You will collaborate closely with cross-functional stakeholders to establish and monitor key performance indicators, support onboarding and capability development, and ensure the long-term sustainability of your team’s knowledge and capacity. Operating in a dynamic matrix environment, you will play a central role in streamlining regulatory operations and aligning submission activities with the broader strategic objectives of the organization.

Who You Are

• You bring 9 to 11 years of professional experience in regulatory publishing and submission management within the pharmaceutical industry, with at least 2 years in a team leadership or supervisory capacity.
• You hold a degree in Pharmacy, Life Sciences, or a related scientific discipline, or equivalent professional experience.
• You have deep expertise in electronic Common Technical Document (eCTD) standards and submission processes, and are recognized as a subject-matter authority in this area.
• You are proficient with regulatory information management platforms and electronic document management systems used in submission workflows.
• You have a proven track record of monitoring and improving compliance with submission standards, Health Authority requirements, and standard operating procedures.
• You communicate with clarity and confidence, and are skilled at building effective relationships with stakeholders across functions and geographies in a matrix organization.
• You demonstrate strong people leadership capabilities, including performance management, coaching, talent development, and fostering an inclusive and engaging team culture.
• You bring familiarity with electronic submission management tools and an interest in continuously improving submission quality and process efficiency.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!