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Job Description
Coordinate and Oversee Biocompatibility & Animal Studies: Managebiocompatibility testing and animal studies for new R&D products.
Liaison between Labs andR&D: Serve as the main communication link between labs and theR&D team to conduct biocompatibility and animal studies.
Strategy Development:Develop and execute strategies for biological assessments of both new andexisting products for regulatory submissions.
Vendor Management:Handle vendor selection for biocompatibility animal studies and bioanalyticallabs including negotiations and scope definition.
Review Compliance Documents:Review study plans reports and amendments to ensure adherence to regulatoryrequirements.
Biological Evaluation Plans:Prepare and review biological evaluation plans and reports in line withregulatory guidelines.
Data Compilation for RegulatorySubmissions: Compile data from nonclinical studies for submissionsto regulatory bodies (DCGI CE and USFDA).
NonClinical Study Justifications: Preparejustifications and rationales for nonclinical studies of R&D products.
Regulatory Query Compliance: Addressqueries raised by regulatory bodies.
Cost Negotiation:Negotiate lab costs to ensure costeffectiveness and justifications for studyprices.
PR Process for NonClinical Studies:Initiate the PR process for nonclinical studies.
Budget Management: Managebudgeting and obtain study approval.
Identify New Labs: Find new certified labs fornonclinical studies to ensure costeffectiveness quality and timelycompletion.
Team Development: Developand train the team to execute nonclinical studies for new R&D products.
Preclinical Research Articles: Prepareresearch articles detailing preclinical studies utilizing animal models.
Requirements
Experience: 25 yrs. of experience of toxicology zoology immunology or pharmaceuticalindustry
Education: M.Sc. Toxicology MSc. Biotechnology MSc. Zoology B.Pharma M.Pharm orrelated field.
Skills: Strongreading 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 OfficeSuite (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. Abilityto work effectively in a team and independently.
Organization: Strong organizational and timemanagement skills with theability to handle multiple priorities and meet deadlines.
Benefits
Increased Innovation
Stronger TeamCollaboration
Clearer CareerPathways
ImprovedDecisionMaking
Enhanced Flexibility
Fostering a Sense ofPurpose
Greater Autonomy
Improved EmployeeRetention
Effective ConflictResolution
Better Risk Management
Higher Quality of Work
Support for ContinuousImprovement
Encouragement ofLeadership Development
StrengthenedOrganizational Culture
Improved ResourceAllocation
Employment Type
Full-Time
