Manager BD

4 months ago

Mumbai, India Abbott Full time

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

(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

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