Assistant Manager/Sr..Regulatory Affairs Officer-Pharma
Job Description:
Job Description: Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations.
? Preparation, Compilation & Review of Registration documents that include Administrative & Technical.
? Reviewing the technical documents provided by QA, QC, Production providing them the report of shortcomings & ensures them to correct the documents.
? Handling RFIs (Requested Further Information’s) queries raised by Importer/ Agent/ Regulatory authorities during evaluation of technical data.
? Coordinating concerned (QA, QC, Production, Packing & Purchase) departments in the process of sample preparation.
? Coordinate & submission of CTD/ACTD/Country Specific Dossiers/DMF (OP) to regulatory agencies.
? Coordinate & provide support to team for preparation and dispatch of regulatory documents & dossiers in agreed time-frames.
? Responsible for planning, coordinating and managing day to day regulatory affairs activities in a timely manner.
? Providing technical knowledge of the data used in CTD, ACTD & Dossiers to members of regulatory team.
? Fill up customer questionnaires by collecting information from various concerned departments.
? good in man - management & co - ordination with all the departments Interact with various administrative, legal & factory departments to collect documents required for regulatory compilation on time.
? Maintenance of the complete history of each drug product.
? Prepare and compliance of Modules-I as per regulatory requirement.
Note: The candidate can work individually.
Key Skills :
Company Profile
Company supplies and exports wide range of pharmaceutical products. Various institutions like hospitals, pharmacies, chemists, pharmaceutical wholesalers, health organizations, medical centers, etc. source our products at competitive prices. company is focusing on expanding into South/Central America, increase its presence in brand marketing in West Africa and also exploring the possibility of starting up operations in CIS and Eastern European markets.
Diverse Product Offerings :
Manufactured as per international set standards (WHO GMP), our products viz; Impotence drugs, antibiotics, antimalarial, anti cancer, NSAIDS, CNS, cardiovascular, anti fungal, liquid injectables, etc. are very effective and reliable. These products are available in dosage forms of capsules, tablets, liquid orals, injectables, and ointments.
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- Interested candidates are requested to apply for this job.
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