Senior Manager-Regulatory Submission Management

Biopharma Careers; Bengaluru; On-site; INR 4,000,000 - 6,500,000; Full time

Job summary

Biopharma Careers seeks a seasoned regulatory submissions leader in Bengaluru. You will head the Submission Management sub-team, ensuring timely, compliant eCTD submissions and publishing excellence across medicines and devices.

You will act as a SME for eCTD and related tools (RIM, eDMS, eSM), guiding teams, coaching staff, and coordinating cross-functional efforts to meet HA requirements.

Qualifications

• Extensive experience in Regulatory Publishing & Submission Management.
• Proven leadership of a submission management sub-team.
• Expertise in eCTD standards and publishing
• Power-user for submission applications (RIM, eDMS, eSM)
• Ensures compliance with health authority (HA) submission requirements.

Responsibilities

• Provide leadership for the Submission Management sub-team and direct the day-to-day operations.
• Coordinate and monitor progress, timeliness, and quality of submissions.
• Contribute to resource planning and onboarding of new hires.
• Act as SME for complex topics and mentoring team members.
• Ensure sustainability of knowledge and capacity for the book of work.

Skills

eCTD expertise

Publishing

Regulatory submissions

Team leadership

RIM eDMS eSM proficiency

Tools

RIM

eDMS

eSM

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.

Accountability:

• Provide leadership and direction for the Submission Management sub-team within Submission Management.
• Accountable for performance and results of Submission Management sub-team team by coordinating and supervising work as a team leader and by monitoring progress, timeliness, completion and quality.
• Contributes to resource planning.
• Acting as SME and solving the problems Supervises the day-to-day business of the Submission Management sub-team also direct support on routine submissions.
• Can perform the work supervised, but typically focuses on the more complex/complicated topics and on managing the team.
• Applies technical expertise in the analysis of factual information and may even look beyond the immediate problem and use business acumen to understand the wider implications.
• Responsible for day-to-day management, setting commitments, coaching and developing employees, performance appraisal, determination of reward outcomes.
• Ensuring sustainability of knowledge, capability, and capacity required for the book of work, aligning with long-term organizational strategies.
• Coordinating training initiatives, including onboarding of new hires, and coaching and mentoring team members.
• Collaborating with the RQS Operations team to establish KPIs and ensure adherence to them, including communication to RQS Operations functions to support overall goals.

Work Experience:

• Around 14 years of professional experience with Regulatory Publishing & Submision Management

Job Specific Competencies:

• Key contact for eCTD and Publishing expertise.
• Act as power-user for submission applications (RIM, eDMS, eSM).
• 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

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!