Senior Specialist Submission Management

Merck Healthcare; Bengaluru; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Merck Healthcare in Bengaluru is seeking an experienced Regulatory Submission Manager to lead planning, compilation, and dispatch of health authority submissions. You will create submission content plans, manage RIM records, and liaise with R&D to ensure timely, submission-ready documents.

Your role requires strong experience in eCTD/NeeS and a track record in regulatory publishing, with excellent communication skills to coordinate with cross-functional teams and external partners.

Qualifications

• MSc or equivalent in Life Sciences; PhD preferred.
• 9–10 years total experience in pharma with 3–6 years in submission management or publishing.
• Experience with a competent authority, academia, or R&D related to regulatory submissions.
• Excellent written and verbal communication skills.

Responsibilities

• Manage planning, compilation, and dispatch of Health Authority submissions.
• Create/update submission packages and content plans for submissions to HA.
• Maintain records in Regulatory Information Management systems and track HA questions.
• Coordinate with R&D to supply submission-ready documents on time.
• Publish and quality-check eCTD output and submit through HA gateways.
• Oversee vendors for submission management and publishing; coordinate queries.

Skills

Communication skills

Regulatory knowledge

eCTD experience

Education

MSc Life Sciences

PhD preferred

Tools

Veeva Vault RIM

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

• Manage and execute planning, compilation, and dispatch of submissions to Health Authorities during the application lifecycle.
• Create and update submission packages and Submission Content Plans for submissions to Health Authorities.
• Create and update records in Regulatory Information Management system and ensure submissions are documented properly in regulatory systems including tracking of HA questions and documentation of approval and registration details in Veeva Vault RIM.
• Liaise and follow-up with R&D functions to provide required submission-relevant documents on time and in submission ready format.
• Publish and perform quality checks, validate eCTD output, and submit eCTDs through supported HA gateway.
• Collaborate with submission management and publishing vendors, resolve, or coordinate any queries, and perform spot checks on output.
• Functional oversight of vendors for submission management and publishing.
• Crisis intervention in case of vendor issues to avoid impact on quality or project timelines.
• Key contact for eCTD and Publishing expertise.
• Act as power-user for submission applications (Veeva Vault RIM).
• Author cover letter and application forms in close cooperation with the License Manager or Regulatory Lead.
• Monitor compliance with submission standards and submission process (internal & external).
• Manage and improve quality of submission standards and templates for submission-relevant documents ensuring compliance with HA requirements.

Who You Are

• Degree in Life Sciences, Medical, PharmD, or a related discipline (minimum MSc or equivalent); higher degree (e.g., PhD) or education in Regulatory Affairs preferred.
• 9–10 years of total experience in the pharmaceutical industry, with 3–6 years in submission management or publishing in eCTD, NeeS, and paper formats.
• Experience in a competent authority, academia, or R&D environment related to the role.
• Excellent written and verbal communication skills

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!