Regulatory Affairs Job at Genedrift | Pharmacy Graduates eligible
Genedrift is hiring for a Regulatory Affairs Job as Officer – Regulatory Affairs in India. B.Pharm and M.Pharm graduates are eligible to apply. The preferred joining date is immediate.
Job Details
Ref No: RV101
Job Code: JP45 – Officer – Regulatory Affairs (DIN11)
Department: Regulatory Affairs(DIN11)
Preferred Joining (in days): Immediate
Reporting To: JP33 – Executive – DIN11 – Regulatory Affairs (DIN11)
Country: India
Regulatory Affairs Job Profile
Perform/Support in review of CMC documentation i.e. CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, and Labelling documents, for filings with HA in emerging markets. This regulatory affairs role requires careful review of filing documentation.
Attend Pre-Submission meetings with the HA and prepare post-meeting package/minutes for internal, client, and HA records.
Assist in the preparation of high-quality dossiers for various markets.
Adequacy Review and Gap Analysis of Technical Documentation for Non-CTD/CTD/ACTD dossier.
Closure of comments with the internal and client teams & review of additional incoming data.
Review and Compilation of Dossier.
Review of shortcomings/ deficiencies/ supplements received from HA and coordinate with internal and client teams for an effective response.
Proper record keeping, complying with internal and client SOPs, while ensuring data security compliance.
Collaborate with internal and external clients for various functional/transition activities, including translation of documents before and post submission to HA.
Prepare customized reports to suit the client’s objectives. Provide regulatory intel, knowledge, and market knowledge to ensure the success of the client’s application.
Supporting and enabling effective and efficient internal and external communication to ensure operational excellence and client satisfaction.
Be meticulous, observant, and thorough while performing any activity and communicating with internal teams and clients.
Demonstrate subject matter and area expertise and high-level knowledge of country regulations and guidelines as updated occasionally through different teams.
Candidate Profile
Strong organizational abilities and skills.
Good interpersonal skills, including problem-solving and oral and written communication.
Excellent computer skills and comfortable with online office applications.
Reasonable knowledge of emerging markets and a keen eye to learn.
Flexible, Adaptive, Ability to work under pressure, work with a focus on delivery, and provide quality outputs within tight timelines.
Qualifications
Post Graduation (Masters in) Pharmacy (M. Pharm)
Graduation (Bachelor of) Pharmacy (B.Pharm)
Age Bracket (Yrs)
25-34
Location
DDN IN
Address
B9, Commercial Complex, Mukherjee Nagar, Delhi, Delhi, 110009, India
This regulatory job is based at the address listed above.