IN-Senior Associate_Functional Expert – Pharma Domain_Intelligent Automation_Advisory_Mumbai

Responsibilities: 

End-to-End Pharma Lifecycle Expertise: 

Provide functional expertise across the full lifecycle of pharmaceutical products, from discovery and preclinical research, through clinical trials, regulatory approvals, manufacturing, distribution, logistics, sales & marketing, QMS and pharmacovigilance. 

Strategic Guidance: 

Collaborate with senior leadership to ensure the integration of best practices, compliance standards, and industry trends across the product lifecycle. Support the business in implementing effective strategies and operational efficiencies. 

Cross-functional collaboration: 

• Work closely with cross-functional teams, including R&D, regulatory affairs, manufacturing, supply chain, sales & marketing, and safety departments, to ensure seamless operations and product delivery. 

Compliacne & Regulatory Expertise: 

• Provide in-depth knowledge of regulatory requirements (FDA, EMA, ICH, etc.) and ensure that products meet all regulatory standards throughout their lifecycle. Guide teams on regulatory documentation, submissions, and approvals. 

Clinical Trials & Data Management: 

• Oversee the design and execution of clinical trials, ensuring they adhere to GxP (Good Clinical Practice) and ICH standards. Support the management of clinical trial data, ensuring compliance with regulatory bodies. 

Manufacturing & Supply Chain Optimization: 

• Ensure manufacturing processes are aligned with quality standards and regulations. Collaborate with manufacturing teams to optimize production, reduce costs, and enhance operational efficiency. 

Pharma covigilance & Drug Safety: 

• Lead pharmacovigilance efforts, ensuring the monitoring of drug safety throughout the lifecycle, including post-market surveillance, adverse event reporting, and risk management. 

Sales & Marketing Support: 

• Provide insights and functional expertise to the sales and marketing teams, ensuring alignment with regulatory standards and successful product launches. Guide the development of promotional materials, advertising, and product claims. 

Training & Knowledge Sharing: 

• Develop training materials and conduct workshops to enhance functional knowledge across teams. Act as a mentor and advisor to junior staff members. 

Continuous Improvement: 

• Evaluate current practices and identify opportunities for continuous improvement in processes, systems, and tools. Propose and implement changes to enhance operational efficiency and compliance. 

Mandatory skill sets: 

• Educational Background: 
  Bachelor’s degree in a scientific or related field (e.g., Pharmaceutical Sciences, Life Sciences, or Chemistry). 

• Experience: 

• At least 4-6 years of hands-on experience in the pharmaceutical industry, with extensive knowledge of the end-to-end product lifecycle. 

• Experience in drug discovery, clinical trials, regulatory affairs, manufacturing, distribution, sales & marketing, and pharmacovigilance. 

• Deep understanding of regulatory frameworks such as FDA, EMA, and ICH guidelines. 

• Proven track record of supporting cross-functional teams in bringing products to market. 

• Skills & Competencies: 

• Strong analytical and problem-solving skills, with the ability to make data-driven decisions. 

• Exceptional communication skills to interact with internal teams, stakeholders, and regulatory bodies. 

• Strong project management skills with the ability to prioritize and handle multiple initiatives. 

• Experience working with pharmaceutical systems (LIMS, ERP, QMS, etc.) is a plus. 

• Certifications (Optional): 

• Certifications such as Certified Pharmaceutical Industry Professional (CPIP) or Project Management Professional (PMP) would be advantageous. 

Preferred skill sets: 

• Experience working with global teams and managing products across international markets. 

• Exposure to digital transformation in the pharmaceutical industry, including automation and data analytics tools. 

Years of experience required: 

4-7 years