Genedrift Current Openings for Astt Manager – Regulatory Affairs
We are having multiple openings in our company in both domestic and internationally
Astt Manager – Regulatory Affairs
Job Profile:
Perform high-quality CMC review of technical documentation i.e. CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, and Labelling documents, for filings with HA in emerging markets.
Attend Pre-Submission meetings with the HA and prepare/ review post-meeting package/minutes for internal, client, and HA records.
Supervise/ assist in the preparation of high-quality dossiers for various markets
Monitor and Supervise the Adequacy Review and Gap Analysis of Technical Documentation for non-CTD/CTD/ACTD dossier. Should have experience in handling and publishing eCTD.
Coordinate with Project lead/ Delivery owner and carefully track project timelines and ensure that deadlines are met.
Periodically review the skill set matrix to ensure that effective count of skill set is always maintained in a team.
Review/ monitor to ensure that proper record keeping for client and internal data is being maintained.
Attend meetings with clients to understand the requirements, delivery areas and feedback/ areas of improvement.
Ensure compliance with QMS practices. Review regulatory intel reports.
Candidate Profile:
Strong project management skills
Excellent interpersonal skills including problem solving, oral and written communication with effective presentation skills.
Excellent computer skills and comfortable with online office applications.
Flexible, Adaptive, Ability to work under pressure, work with a focus on delivery, and provide quality outputs within tight timelines.
Candidates with exposure in Parentrals, Biologics, Biosimilars, Vaccines preferred
Experience of working with TGA Australia preferred
Experience (Min Yrs) 5
Qualifications Post Graduation (Masters in) Pharmacy (M. Pharm)
Graduation (Bachelor of) Pharmacy (B.Pharm)
Age Bracket (Yrs) 25-34
Type Office and WFH
The candidates can apply through the website directly https://www.genedrift.com/openings
Or can also mail us –
[email protected]
Thank you
