Manage end to end project. 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
Preparation of project plan and execution
Coordinate with Ops BD for scouting new product from various TPMs as per list provided by commercial team
Coordinate with BU & Finance for product margins
Managing global NPI process – Through E2E portal (Planisware)
Support site and product screening in terms of QA and Regulatory compliance, Organize and arrange transfer price for the product and QA audit for the site, follow up for CAPA. Keep tech ops and SCM team informed on product and site
Support TPM for product manufacturing license, arrange product license and complete technical dossier from TPM for QA/Regulatory/Medical. Follow up with cross functional team for gap analysis and arrange product dossier compliance from TPMs. Get site and product approval certification. Support to close product supply agreement and quality agreement
Support and monitor art work design and development activities; close coordination with Legal & Marketing for brand name , Regulatory for Rule 96 and D & C act compliance , Medical for rationale & PIL design , Quality for over all labeling compliance as per AIL branding guide lines & as per Rule 96 and D & C act
Based on sale and physician sample projection decide adequate batch size with Ops BD and TPM. Close raw material and packaging material specifications and finished good specification in consultation with Quality/Regulatory/Tech Ops and Ops BD. Coordinate for SAP code creation and follow up for purchase order
Responsible for first three month supplies of NPI for 2 years
Managing new product technical complaints (PTC), support cross functional team to get resolved product complaints in consultation with TPM / Ops BD / RA /QA; if required arrange personal visit to the site.
People Management (Responsibility for leading, motivating and developing staff)
Individual contributor role however multiple cross functional alignment and working required
TPM/CFT for product compliance
Financial Responsibilities (Budget and financial authority limits)
* No financial Authority -
Internal and External Coordination
Internal
Marketing
Interacts for responding to technical queries from doctors and field force , catering to specific marketing requirements, change in pack size, design, etc., and providing unique ideas to them.
Legal
Interact for closing product development and product supply agreement or addendum to agreement
Finance
Interacts for product cost, MRP ,NPPI & DPCO , Product development payments
Medical/Pharmacovigilance
Interacts for providing support for new product medical rational ,regulatory compliances and answering queries related to ADR
Quality
Interacts for site audit, dossier review, product certification, art work clearance product complaint.
Ops BD / Tech Ops
Interacts for evaluation of new products dossier & product certification and product deliveries
Packaging development /Ops BD and SCM
Interacts Packaging development team for art work and Ops BD / SCM for logistic support
External
TPMS
Interacts for product along with Ops BD for license application & support, art work activity support, RM & PM procurement follow up, production planning, commercial production and dispatch.
Vendors
Interacts with vendors for on line proof approval, RM & PM deliveries
FDA, DCGI, Customs
Connect and support TPMS if possible for necessary product permissions, licenses, import permissions, certificates (WHO GMP, COPP, Non conviction etc)
Competencies
Functional Knowledge (Product commercial working / Project plan execution)
Managerial Expertise
Negotiation skills
Networking and Relationship building
Problem Solving and Decision Making
Communication and interpersonal skills
Digital Expertise
Job Requirements
Qualification :
Master’s degree in Pharmacy from reputed Institute and/or MBA (preferably with a science background)
Work Experience :
8 -10 years of relevant experience in overall pharmaceutical formulation operations
Additional Requirements :
The incumbent should have knowledge of Quality Assurance (QA), Quality Control (QC), and regulatory guidelines