India's s oldest and most admired healthcare companies which provide consumers with a diverse range of diagnostics solutions, medical devices & nutritional products is looking to hire a Sr. Manager / Manager NPI for their Mumbai Office.
Department: Therapy Area Strategy & New Products Introduction
Reports To : Associate Director – NPI & TAS
Responsible for coordinating and executing various technical, legal, and regulatory activities related to new product development, contract manufacturing and new product delivery. Responsible for ensuring availability of quality new products for meeting sales targets. Responsible for business development for AIL
Job Duties and Responsibilities
â–ª End to end project management for new products introduction
â–ª Scouting new products from various TPMs based on organization needs
â–ª Align the following with QA / RA / OPS BD etc: Site and product screening in terms of QA and Regulatory compliance, negotiating on transfer price for the product, working on additional investment proposals with TPMs.
â–ª Support TPM for product manufacturing license, procuring product license and complete technical dossier from TPM for QA/Regulatory/Medical and technical operation review and gap analysis.
â–ª Follow up with cross functional team for gap analysis, product dossier compliance from TPMs, site and product approval certification. Support to close product supply agreement and quality agreement
â–ª Accountable for tracking all the new product activities including development activities on a project management basis with cross functional working across QA, medical, regulatory, finance, tech ops, Opsn BD, distribution, supply chain, IFO, SAP & purchase teams. Project managing end to end allocated
divisions for new product initiatives with internal process alignment.
â–ª End to end formulation development support to TPM including commercial working, product the development agreement,literature survey, DCGI or state license application, compatibility check pre formulation trials, proto type sample approval from marketing, stability batches manufacturing, documentation and stability studies follow up and compliance.
â–ª Responsible for the planning, management, coordination and financial control of the projects
â–ª Responsible for implementation of global NPI process including but not limited to global end to end system.
â–ª Supporting in – licensing deals by creating compelling business case and aligning commercial teams with expectations of deal partners.
Core (Technical / operational responsibilities e.g. functional duties, financial mgt., project management)
â–ª Individual contributor role however cross-functional alignment and working with multiple stakeholders required.
â–ª Internal commercial team negotiations on budgets
â–ª Responsible for the NPI financial numbers & plan submissions
â–ª Should have a sound understanding of financial principles Internal and External Coordination required
â–ª Marketing : â–ª Responding to technical queries from doctors and field force (technical and regulatory), catering to specific marketing requirements, change in pack size, design, etc., and providing unique ideas to them. Provides regulatory documents to gain tenders (institutional business). Provides Certificate of Analysis required for supporting tender business. Provides registration dossiers and documents for countries like Nepal, Sri Lanka Myanmar etc.
â–ª Legal : â–ª Product development and product supply agreement
â–ª Regulatory â–ª Regulatory clearances
â–ª Finance : â–ª Product cost, MRP,NPPA & DPCO, Product development cost & payments
â–ª Medical/Pharmac ovigilance
: â–ª Support for new product medical rational,regulatory compliances and answering queries related to ADR
â–ª Quality :
â–ª Interacts for site audit, dossier review, product certification, art work clearance product complaint.
â–ª Tech Ops : â–ª Interacts for evaluation of new products dossier & product certification.
â–ª Ops BD â–ª Interact for TPM alignment on all aspects related to planning and delivery of identified products
â–ª I&D â–ª Interact for planning & coordination for I&D development opportunities identified
â–ª Packaging development and SCM:
â–ª Interacts with packaging development team for art work activities, on line proof
clearance, new packaging options etc. Interacts with SCM for providing
information on existing TPMs /product available on shelf with TPMs/ product
available in other BU. Logistic support
External People Management (Responsibility for leading, motivating and developing staff)
Financial Responsibilities (Budget and financial authority limits)
â–ª TPM ( third party manufacturing/ contract manufacturing)
â–ª Interacts for product development, stability programs, license application & support, transfer price, art work activity support, RM & PM procurement
follow up, production planning, commercial production and dispatch. On line training to staff for AIL-NPI processes, product development and QA/Regulatory compliance requirements etc
â–ª FDA, DCGI, Customs
: â–ª Connect and support TPMS if possible for necessary product permissions, licenses, import permissions, certificates (WHO GMP, COPP, Non conviction etc)
â–ª Testing labs : â–ª Interacts for sending samples to testing labs to ascertain quality standards of AIL products, reviewing the test reports, and testing of new products which are to be purchased from a business development perspective
â–ª New product scouting
â–ª Creating new opportunities for growing the business by identifying new business opportunities
â–ª Building a comprehensive business case for selected product OR opportunities including an overview of all development/ launch activities Assisting the new product team in identifying / evaluating new drug / from a marketing perspective (NPV analysis etc)
â–ª Attend global and local conferences to get access to globally available
opportunities (adding value to playbook)
Communication & interpersonal skills
Functional Knowledge (Quality/Regulatory/Product
development & production)
Sound financial understanding
Management and leadership skills
Problem Solving and Decision Making
Qualification:Any bachelor's or masters degree in science / Pharma