Novumgen Hiring Regulatory & Scientific Affairs Executive | Pharmacology Freshers Preferred Only

Novumgen was founded by a group of experienced pharmaceutical professionals with the goal of developing and producing innovative, high quality medicines. The company quickly established itself as a leader in the UK market, and soon began licensing its products in other countries around the world.

HIRING FRESHERS ONLY
ONLY PHARMACOLOGY SPECIALIZATION CANDIDATES CAN APPLY

Post : Executive - Regulatory & Scientific Affairs

Experience : 0-1 Year (Freshers Encouraged)
Qualification : M.Pharm (Pharmacology) Freshers Preferred Only Pharmacology specialization candidates can apply

KEY RESPONSIBILITIES
SCIENTIFIC LITERATURE RESEARCH
• Conduct literature searches using scientific databases
• Review, summarize and organize scientific data
SCIENTIFIC & REGULATORY WRITING
• Assist in preparation of CTD modules (2.4. 2.5, 2,6. 2.7)
• Support scientific reports, justifications and regulatory responses
CLINICAL & NON-CLINICAL ASSESSMENT
• Review clinical, non-clinical, toxicology, pharmacology and BA/BE studies Assist in evaluating efficacy, safety and PK/PD data REGULATORY AFFAIRS SUPPORT
• Assist in dossier preparation and compilation Monitor global regulatory updates and requirements

KNOWLEDGE & EXPOSURE
Pharmacology, Toxicology, Clinical Research
BA/BE Studies, Drug Development © CTD
ICH, EMA, US FDA, Health Canada. WHO Guidelines
CTD Structure & Benefit-Risk Assessment
GCP & GLP Awareness

SKILLS & COMPETENCIES
TECHNICAL SKILLS
Literature searching & data retrieval Scientific writing & documentation Understanding of clinical & non-clinical study designs Interpretation of scientific publications Proficiency in MS Office & research tools
SOFT SKILLS
Strong communication Analytical & critical thinking Attention to detail Quick learner & adaptable Time management Team player