Meril Hiring for Executive at Pardi, Gujarat, India Full Time

• Liaison between Labs and R&D: Serve as the main communication link between labs and the R&D team to conduct biocompatibility and animal studies.
• Strategy Development: Develop and execute strategies for biological assessments of both new and existing products for regulatory submissions.
• Vendor Management: Handle vendor selection for biocompatibility, animal studies, and bioanalytical labs, including negotiations and scope definition.
• Review Compliance Documents: Review study plans, reports, and amendments to ensure adherence to regulatory requirements.
• Biological Evaluation Plans: Prepare and review biological evaluation plans and reports in line with regulatory guidelines.
• Data Compilation for Regulatory Submissions: Compile data from non-clinical studies for submissions to regulatory bodies (DCGI, CE, and USFDA).
• Non-Clinical Study Justifications: Prepare justifications and rationales for non-clinical studies of R&D products.
• Regulatory Query Compliance: Address queries raised by regulatory bodies.
• Cost Negotiation: Negotiate lab costs to ensure cost-effectiveness and justifications for study prices.
• PR Process for Non-Clinical Studies: Initiate the PR process for non-clinical studies.
• Budget Management: Manage budgeting and obtain study approval.
• Identify New Labs: Find new certified labs for non-clinical studies to ensure cost-effectiveness, quality, and timely completion.
• Team Development: Develop and train the team to execute non-clinical studies for new R&D products.
• Preclinical Research Articles: Prepare research articles detailing preclinical studies utilizing animal models.

Requirements

• Experience: 2-5 yrs. of experience of toxicology, zoology, immunology or pharmaceutical industry
• Education: M.Sc. Toxicology, MSc. Biotechnology, MSc. Zoology, B.Pharma, M.Pharm or related field.
• Skills: Strong reading, writing and communication skills.
• Knowledge: Familiarity with regulatory requirements and guidelines (e.g., ICH, FDA, EMA). Experience with clinical trial protocols and data.
• Software Proficiency: Competency in Microsoft Office Suite (Word, Excel, PowerPoint) and familiarity with reference management tools (e.g., Pub Med, Elsevier) and document management systems.
• Communication: Excellent verbal and written communication skills. Ability to work effectively in a team and independently.
• Organization: Strong organizational and time-management skills with the ability to handle multiple priorities and meet deadlines.

Benefits

• Increased Innovation
• Stronger Team Collaboration
• Clearer Career Pathways
• Improved Decision-Making
• Enhanced Flexibility
• Fostering a Sense of Purpose
• Greater Autonomy
• Improved Employee Retention
• Effective Conflict Resolution
• Better Risk Management
• Higher Quality of Work
• Support for Continuous Improvement
• Encouragement of Leadership Development
• Strengthened Organizational Culture
• Improved Resource Allocation