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Manager, Planning & Administration

Astellas
Astellas
3-7+ years
Not Disclosed
Bengaluru, India
10 Feb. 19, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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

Manager, Planning & Administration – Regulatory Affairs & Pharmacovigilance (RAPV) | Bengaluru, India (Hybrid)

Location: Bengaluru, India
Department: Regulatory Affairs & Pharmacovigilance (RAPV) / Global Capability Centre
Employment Type: Full-Time | Hybrid

ThePharmaDaily.com is featuring a strategic leadership opportunity for a Manager, Planning & Administration based in Bengaluru, India. This role is designed for experienced pharmaceutical professionals with strong expertise in regulatory operations, portfolio management (PMO), training management systems (LMS), and Records & Information Management (RIM) within GxP-regulated environments.

This position plays a critical role in driving operational excellence across RAPV functions, supporting non-drug project portfolios, business planning cycles, compliance oversight, and global stakeholder coordination.

Role Overview

The Manager, Planning & Administration collaborates with global stakeholders to execute major Planning & Administration programs and continuous improvement initiatives. The role contributes to the RAPV Portfolio/PMO by maintaining oversight of non-drug project portfolios and serving as Project Manager for selected initiatives.

In addition, the role oversees operational management of Training Management systems (including LMS and Good Pharmacovigilance Practices compliance) and Records & Information Management (RIM), ensuring global alignment, audit readiness, and service quality across regions.

Key Responsibilities

Portfolio & Project Management (PMO – Non-Drug Initiatives)

  • Maintain oversight of the RAPV non-drug project portfolio in collaboration with global PMO stakeholders.

  • Serve as Project Manager for selected strategic initiatives, ensuring timely delivery and measurable outcomes.

  • Drive process improvement and organizational transformation initiatives across regulatory and pharmacovigilance functions.

  • Coordinate cross-functional priorities across global committees and stakeholder groups.

  • Anticipate and proactively resolve project, procedural, or governance-related risks.

Business Planning, Budget & Resource Management

  • Contribute to annual, mid-term, and long-term business planning cycles within RAPV.

  • Support budget forecasting, financial analysis, and scenario planning.

  • Partner with CRDO and other stakeholders on resource tracking and capacity planning.

Training Management (LMS & GVP Compliance)

  • Oversee implementation and operational management of the Learning Management System (LMS), including Good Pharmacovigilance Practices (GVP) compliance.

  • Monitor training compliance metrics and execute remediation plans as needed.

  • Ensure audit-ready documentation and global training governance alignment.

Records & Information Management (RIM)

  • Maintain RIM procedures and internal controls to support regulatory documentation integrity.

  • Support audits and inspections, including preparation of corrective and preventive actions (CAPAs).

Governance & Business Continuity

  • Support maintenance and activation readiness of the Business Continuity Plan (BCP).

  • Coordinate global stakeholders across time zones to ensure alignment and consistent service delivery.

Experience Required

  • Minimum 7+ years of experience in regulatory operations, pharmacovigilance operations, or a similar role within the pharmaceutical industry.

  • At least 3+ years of program or project leadership experience, including PMO or portfolio oversight for non-drug initiatives preferred.

  • Proven experience working within GxP-regulated processes and regulatory documentation environments.

  • Demonstrated expertise in Training Management Systems (LMS, including GVP compliance).

  • Experience supporting Records & Information Management (RIM) operations.

  • Strong experience in cross-functional coordination across global regions and time zones.

  • Ability to manage multiple concurrent projects with strong prioritization skills.

Educational Qualifications

  • Bachelor’s degree required (Pharmacy, Science, Technology, or related discipline preferred).

  • Project management certification such as PMBOK or PRINCE2 is advantageous.

Core Competencies

  • Regulatory operations and pharmacovigilance expertise

  • Portfolio and project management leadership

  • Budgeting and resource planning capabilities

  • LMS governance and GVP compliance oversight

  • RIM operations and audit readiness

  • Change management and process transformation

  • Strong analytical and problem-solving skills

  • Excellent written and verbal communication in English

  • High integrity and ability to manage confidential information

Work Environment

This role follows a hybrid working model in Bengaluru, balancing on-site collaboration with remote flexibility in alignment with Responsible Flexibility Guidelines.

Why This Role is Strategically Significant

  • Direct impact on global RAPV portfolio governance and operational strategy

  • Leadership exposure within Planning & Administration functions

  • Integration of PMO, LMS, and RIM governance under one strategic role

  • Opportunity to drive compliance, transformation, and operational excellence in a global pharmaceutical environment

  • Career pathway toward senior regulatory operations or global program leadership roles

Professionals with expertise in regulatory operations, pharmacovigilance governance, PMO leadership, LMS compliance, RIM management, and GxP-controlled environments are encouraged to apply.