Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Business Partner – Regulatory Operations

8-10 years
Not Disclosed
10 Sept. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Job Title: Business Partner – Regulatory Operations
Location: Chennai, India
Department: Regulatory Affairs
Reports To: Manager
Employment Type: Full-Time

Educational Qualification:

  • Graduate in Life Sciences


Job Purpose:

Lead and manage regulatory operations projects, ensuring quality, compliance, and timely submissions, while coordinating resources and processes to support business objectives.


Key Responsibilities:

Regulatory Operations Management:

  • Develop and manage day-to-day operations using project management and planning tools; create and maintain detailed project timelines.

  • Coordinate and maintain quality, productivity, and adherence to timelines, internal processes, and customer standards.

  • Plan resources to support submissions publishing and regulatory affairs activities, including short- and long-term resource planning.

  • Manage projects by regularly meeting with team leads to identify and resolve issues, ensuring quality and delivery effectiveness.

Process & Documentation:

  • Initiate, author, and/or collaborate on SOPs, work instructions, and workflows for the regulatory operations function.

  • Plan, coordinate, and prepare responses to Requests For Proposals (RFPs), Requests For Information (RFIs), and Requests For Quotes (RFQs).


Required Skills & Competencies:

  • 8–10 years of experience in regulatory operations.

  • Expertise in both Publishing and Submissions.

  • Strong understanding of regulatory information management concepts and tools.

  • Excellent communication and coordination skills.