SPL Specialist: Regulatory Compliance Expert
4 weeks ago
Job Description: We are seeking a highly skilled SPL Specialist to join our team at Genpact. As a key member of our regulatory compliance team, you will be responsible for creating and managing FDA-required Structured Product Labeling (SPL) documents for our clients.
Key Responsibilities:
- Creation and management of FDA-required SPL documents, including labeling, bulk drug listing, establishment registration, and blanket no-change certifications.
- Preparation of new SPL as per client requirements, ensuring accuracy and consistency throughout the process.
- Update existing SPL as per client requirements, maintaining a high level of quality and attention to detail.
- Formatting of SPL documents according to client standards, ensuring proper alignment, spacing, and line breaks.
- Quality control of SPL to ensure correctness, including link references, tables, figures, sections, and hyperlinked TOCs.
- Successful submission of SPL listings to FDA without any validation issues or rejections.
- Professional use of SPL preparation tools and basic knowledge of XML language.
Qualifications:
- Minimum qualification: M.Pharma/B.Pharma or any other relevant life science graduate.
- Good proofreading and typing skills, with a strong understanding of client requirements.
- Familiarity with labeling, eCTD submissions, and document management.
Desirable Skills:
- Efficient use of SPL tools, Adobe Acrobat, and MS Word.
- Ability to conduct quality reviews of documents by peers.
- Expertise in resolving queries and troubleshooting technical issues.
- Adaptability in a changing environment, with flexibility towards process changes.
- Ability to work effectively in a collaborative team environment.
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