Senior Executive
2 months ago
Job Responsibilities:
1. Provide Medico-regulatory support for registration of pharmaceutical products globally (fresh, variations and renewals): Medical support for fresh/renewal/variation filings in Europe, Australia, South Africa, WHO, India and other emerging markets in line with CTD modules and applicable regulatory guidelines. Provide Labels (prescribing information, summary of product characteristics, patient information leaflets, medication guides), Expert reports (clinical expert report, non-clinical expert reports, medical data packages). Support bibliographic filings and provide published literature for annual reports for NDAs in USA.
2. Provide Medico-regulatory support for Differentiated Drug Projects/ B2/Hybrid Filings - Medical support for B2 (preIND/IND) and NDA regulatory dossier filings in USA/EU/AU/Canada. Drafting/reviewing proposed labels, medical rationales, initial pediatric study plans, study synopsis, clinical overviews, safety reports, Investigator brochures, 5-pagers etc. 3. Provide medical inputs for Medical Rationales, New Product Evaluations, New Product Ideas, Target Product Profiles, Concept Notes: Evaluate new drug product proposals/fixed dose combinations/First to File (FTFs); and propose new product ideas. Medical support to R&D, BD and marketing and participate in assigned due diligence.
4. Proposals on Bio-Equivalence Study Designs/Bio-recommendations: BE study designs proposals based on applicable guidelines such as EMA, TGA, Health Canada, USFDA BE guidance and review of BE study reports. Management of medical Bio-waiver documents to extend US BE studies to Canada submissions.
5. Health Hazard Evaluations (HHEs): Provide Health Hazard Evaluations as per organization requirements & supervise the work flow management for HHE deliverables. Medical inputs for HHE due to product quality complaints (PQCs)/Out of specification (OOS) results basis requests received from manufacturing plants
6. Work flow & People management and Cross-Functional Interaction: Supervise the work flow management, direct stakeholder engagement, streamlining of processes, and optimizing output by the team via mentoring and training while meeting individual, group and organizational objectives. Setting goals for staff and assessing individual performance and achievements per company HR processes. Performing regular reviews and appraisals for team members and providing appropriate feedback. Ensuring data collection and preparation of metrics to be shared with senior management.
Representation of the department in cross functional discussions for planning and tracking filing portfolio development/ agency query response management and attend GRCs for health hazard evaluation discussions.
7. Standard Operating Procedures (SOPs): Preparation/review of applicable SOPs and operational strategies. Ensure compliance to SOPs and regulatory guidelines.
List of Competencies Required:
Technical Competencies:
• Educational requirement: MBBS / MD / BDS / PhD / MPharm • Domain knowledge: Medical & therapeutic area knowledge; thorough knowledge of drug development process and pharmacology
• Knowledge of regulatory and scientific guidelines
• Literature search skills: Application of well-planned search strategy, appropriate keywords and a variety of sources when researching journal articles and medical research papers
• Literature review & interpretation skills: Performing critical content reviews with clear objectives; logical and accurate research data interpretation
• Literature compilation skills: Logical and accurate representation of the data in text, tables, and graphs, and developing logical discussion and conclusions
• Writing skills: Draft high quality documents with correct formatting & editing skills. Consistency & uniformity in documents with attention to detail. Good knowledge of working on word, excel and power point
• Keeping abreast of new relevant information in pharmaceutical industry, and undergo regular self-training to enhance skills
Behavioral Competencies / Soft Skills:
• Willingness to learn
• Reliability and having proactive approach
• Time management skills to deliver high quality documents within stipulated timelines
• Decision making skills including prioritizing assignments as per organizational requirements
• Interpersonal skills and team spirit with willingness to help others in achieving targets
• Problem solving skills & willingness to work in tight schedules if required by the organization to support drug filings and approvals
• Good Communication skills
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