Job Summary
The Executive – Regulatory & Scientific Affairs will support scientific, clinical, and regulatory activities associated with pharmaceutical product development and lifecycle management. The role involves conducting comprehensive literature reviews, preparing clinical and non-clinical regulatory documents, supporting regulatory submissions, and contributing to scientific evaluations in accordance with global regulatory requirements.
Key Responsibilities
Scientific and Literature Research
- Conduct comprehensive literature searches using scientific databases such as PubMed, Embase, Cochrane Library, and regulatory agency databases.
- Perform secondary research to gather scientific, clinical, toxicological, and regulatory information from journals, publications, public databases, and health authority resources.
- Evaluate and summarize scientific evidence to support product development and regulatory submissions.
- Regulatory Writing and Documentation
- Assist in the preparation and review of Clinical Overviews, Clinical Summaries, Non-clinical Overviews, and Non-clinical Summaries (CTD Modules 2.4, 2.5, 2.6, and 2.7).
- Support the development of scientific justifications, gap analyses, benefit-risk assessments, and regulatory briefing documents.
- Contribute to preparation of dossiers and responses for submissions to global regulatory authorities.
Clinical and Non-Clinical Evaluation
- Review and interpret published clinical and non-clinical data.
- Analyze toxicity studies, pharmacology studies, pharmacokinetic data, bioequivalence studies, and clinical trial reports.
- Support scientific assessment of efficacy, safety, and benefit-risk profiles of pharmaceutical products
Regulatory Affairs Support
- Assist in evaluating regulatory pathways and submission strategies for pharmaceutical products.
- Monitor and interpret updates from major regulatory agencies, including:
o European Medicines Agency (EMA)
o United States Food and Drug Administration (US FDA)
o Medicines and Healthcare products Regulatory Agency (MHRA)
o Health Canada
o Therapeutic Goods Administration (TGA)
- Support pre-submission planning, regulatory intelligence activities, and product lifecycle management.
Required Skills and Competencies
- Strong literature searching and scientific data interpretation skills.
- Understanding of pharmaceutical development, clinical research, and regulatory requirements.
- Knowledge of toxicity studies, BA/BE studies, and clinical trial methodologies.
- Scientific and regulatory writing skills with attention to detail.
- Ability to critically analyze scientific publications and regulatory guidance documents.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Effective verbal and written communication skills.
- Ability to manage multiple assignments and work within timelines.
- Strong organizational, analytical, and problem-solving abilities.
- Self-motivated, proactive, and capable of working independently as well as within cross-functional teams.
Preferred Skills
- Familiarity with CTD/eCTD dossier structure.
- Experience with scientific databases and regulatory portals.
- Exposure to medical writing, clinical evaluation reports, or regulatory submissions.
- Knowledge of ICH, EMA, US FDA, Health Canada, and other international regulatory guidelines.
Key Attributes
- Scientific curiosity and attention to detail.
- Strong analytical mindset.
- Commitment to quality and regulatory compliance.
- Ability to learn quickly and adapt to evolving regulatory requirements.
- Collaborative team player with a professional approach
