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Business Partner – Regulatory Operations

8-10 years
₹30 LPA – ₹45 LPA
10 July 22, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Business Partner – Regulatory Operations
Location: [Not specified]
Experience Required: 8–10 years
Job Type: Full-Time


Job Description:
We are currently looking for a Business Partner – Regulatory Operations to join our team. This strategic role focuses on managing regulatory operations and submission planning by leveraging expert knowledge of publishing, regulatory standards, and cross-functional coordination. The candidate will be responsible for maintaining quality, managing timelines, and optimizing processes across regulatory functions.


Key Responsibilities:

Project & Resource Management:

  • Lead and manage day-to-day regulatory operations, ensuring effective coordination using project management tools.

  • Create, maintain, and track detailed submission project timelines.

  • Plan and allocate appropriate resources for both short- and long-term publishing and submission-related activities.

  • Coordinate with project teams and conduct regular reviews with team leads to monitor delivery, quality, and issue resolution.

Operational Excellence:

  • Drive adherence to internal and customer standards, ensuring compliance, productivity, and quality.

  • Lead efforts in drafting and maintaining SOPs, work instructions, and workflows related to regulatory operations and submissions.

Strategic Collaboration & Business Support:

  • Serve as a key regulatory operations partner across cross-functional business units.

  • Support strategic business needs by responding to RFPs, RFIs, and RFQs.

  • Drive continuous improvement across regulatory processes and support business development functions.


Desirable Skills and Experience:

  • 8–10 years of experience in regulatory operations with strong expertise in both Publishing and Submissions.

  • Sound understanding of information management systems, regulatory requirements, and tools supporting global submissions (e.g., eCTD).

  • Proven ability to lead cross-functional teams, coordinate with stakeholders, and manage multiple complex projects.

  • Strong interpersonal, organizational, and communication skills—written and verbal.


Estimated Salary: ₹30 LPA – ₹45 LPA (based on experience and domain expertise)