Sr. Associate – RA _ Publishing _Gurugram (Onsite)
Full Time
Gurgaon
Posted 2 days ago
Job Descriptions
- Provides regulatory publishing and submission support and oversight.
- Publishes Regulatory documents with Docubridge software application for initial submissions as well as, routine/ maintenance submissions to support active applications such as supplements and periodic reports.
- Trouble-shoots issues related to the published submissions.
- Collaborate with submission content contributors, regulatory leads and project management in the planning and preparation of submission components.
- Manage and execute assembly, publishing and timely submission of regulatory applications.
- Provides guidance (and where necessary training) to Regulatory Affairs staff on all aspects of submission formats/requirements and publishing related software/tools as and when required.
- Act as a Subject Matter Expert for publishing tools and standards.
Education & Experience
- Bachelor’s degree in pharmacy, Life Sciences, Biotechnology, Chemistry, or related scientific field. A master’s or higher is preferred.
- Hands‐on experience in publishing software (Lorenz is preferred) for submitting dossiers for US (FDA) and EU (EMA or national authorities).
- Strong knowledge of eCTD and validation requirements.
- Excellent written and spoken English; strong documentation skills.
- Minimum 2-5 years of publishing experience, with substantial exposure to the validator tools.
Location
Gurgaon, Haryana (Onsite) (INDIA)