Key duties of the job include:
- studying scientific and legal documents
- gathering, evaluating, organising, managing and collating information in a variety of formats
- ensuring compliance with USFDA, MHRA regulations
- maintaining familiarity with company product ranges
- planning, undertaking and overseeing product trials and regulatory inspections
- keeping up-to-date with changes in regulatory legislation and guidelines
- analysing complicated information, including trial data
- offering advice about company policies, practices and systems
- obtaining marketing permission
- outlining requirements for labelling, storage and packaging
- using a variety of specialist computer applications
- liaising and negotiating with regulatory authorities
- providing advice about regulations to manufacturers/scientists
- writing comprehensible, user-friendly, clear product information leaflets and labels
- ensuring that quality standards are met and submissions meet strict deadlines
- preparing documentation.
Qualifications and training required
The minimum necessary qualification is an appropriate subject (chemistry, physics, biochemistry, biotechnology, pharmacy, medicinal chemistry, biomedical science, life or applied science).A relevant postgraduate qualification (PhD or research-based MSc) is also helpful, particularly for permanent positions. Post-doctoral research, practical research or laboratory work experience is also beneficial - regulatory affairs experience is particularly sought after. Certification in Regulatory Affairs [USFDA, MHRA, CDSCO, EU etc.] may be highly helpful to get jobs.
Key skills for Regulatory Affairs professionals
- IT skills
- Negotiation skills
- Analytical skills
- Time management skills
- Problem solving skills
- Presentation skills
- Interpersonal skills
- Communication skills
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