Skills
1.Preparation of technical documents like, Specs, COA, Method of analysis of raw materials and
finished products and stability summary sheet etc.
2. Co-ordinate with different departments in plant to arrange the data for documents preparation.
3. Provide the required technical documents of the products to the regulatory team in corporate office.
4. Takes follow ups for preparation and testing of samples (In house as well as from outside lab).
5. To maintain all records of technical documents.
6. Should have knowledge of regulatory domain.
7. Should be well versed with the protocols and process involved in the documentation.
JOB DESCRIPTION:
1. Dossier preparation, review submission in ACTD/ CTD/ Country Specific format for Product registration for local and export to ensure error free timely submissions as per marketing Dept. timeline.
2. To evaluate respond to any regulatory query, customer requirements that may arise from health authority so as to satisfy the query. Ensure accurate and timely responses to queries.
3. Review technical documents like process validation, AMV, Stability and composition etc, labeling, batch records, specification sheets or test methods for compliance with applicable regulations and policies.
4. To Co-ordinate / to visit with respective dept. in HO / Plant / ADL / R D for documents samples required for dossier / registration purpose. Co-ordination with API / PM vendors to resolve technical quires w.r.t. regulatory requirements.
5. Artwork Checking development for registration and commercial purpose as per regulatory requirement Ensure that all product artwork is updated when necessary and submitted in correct format and subsequent approved artwork is accurately recorded and communicated. Handling local FDA, DCGI and regulatory related activities.
6. Ensuring accurate recording and communication of regulatory submissions, correspondence with authorities and final approval to facilitate compliance.
7. Carrying out any task delegated by Export Manager which contributes to overall running of the Export Department and assisting Export Manager in marketing business development activities. Participate in training activities for career development to attain a high level of competency in all aspects of regulatory affairs. Maintain current knowledge base of existing and emerging regulations, standards or guidance documents.