Job Title: Sr. Executive - Business Development
Roles and Responsibilites
- Prepare Dossier PIF and share with regulatory team for dossier compilation upon receiving instruction from BD Manager after agreement execution with customer.
- Deliver product registration dossiers to customer within agreed timeline by coordinating with Regulatory Team.
- Ensure delivery of pre product registration related query responses to client by coordinating internally with cross functional teams.
- Managing the post-deal drug registration process and ensuring 100% regulatory compliance.
- Developing detailed project plans, timelines and budget to ensure project objectives are met.
- Timely follow-up with each client to ensure products registration on time for execution of budgeted new product launch.
- Arrange and deliver registration samples, product testing materials & other GMP documents to each client through internal co-ordination with regulatory and plant team.
- Coordination & execution of Quality/Technical Agreement & Safety Data Exchange Agreement with client through internal co-ordination with plant QA team & Lambda Pharmacovigilance team.
- Preparing and presenting monthly report on each assigned project to reporting management.
- Ensuring timely execution of project & completion in adherence to SOPs.
- Monitoring progress of the project and dynamically adjusting plans as necessary to achieve 100% on-time completion rate.
- Ensuring all project activities comply with pharmaceutical regulations (FDA, EMA, etc.) and Good Manufacturing Practices (GMP).
- Demonstrating accuracy on each project phase to improve quality & performance.
- Tracking project expenditures to ensure adherence to the budget.
Qualification Required
B. Pharma/MBA
Competencies
Relevant skills / Industry experience
- Project Planning & Execution – Developing project timelines, workstreams, and deliverables
- Stakeholder Management – Collaborating with cross-functional teams (R&D, regulatory, manufacturing, QA, etc.)
- Risk Management – Identifying, assessing, and mitigating risks throughout the project lifecycle
- Regulatory Affairs & Compliance – Knowledge of EMA, ICH, GMP, GCP, and other regulatory requirements
- Pharmacovigilance & Safety – Ensuring drug safety and reporting adverse events
- Communication & Negotiation – Interfacing with stakeholders, vendors, and regulatory bodies
Relevant professional / Educational background
5+ Years’ experience in QA/RA department in Pharmaceutical Industry
Compensation / Reward
As per Industry Standard
Head Office, Ahmedabad, GJ, IN, 380054