Senior Associate, Regulatory Affairs Submission Management - AbbVie - Florham Park, NJ
(2022-08)
- Manages medium to high impact submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
- Acts like RA Submissions interface with project teams providing guidance and communication of established submission processes and standards. Provides input to project scope, especially as it impacts publishing timelines and deliverables.
- Plans and conducts submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects and/or for multiple products in the delivery of moderately complex published submissions within the required timelines. Anticipates obstacles and develop solutions within the team.
- Main responsibility includes working on IND/NDA/BLA to support the timeline. At the same time, also maintaining CTA/CTR and Brazil submissions to get the approval in all those countries.
- May be a technical Subject Matter Expert troubleshooting issues and providing technical systems support.
- Facilitates the creation or procurement of submission content deliverables such as cover letters and forms.
- This contributes to the development of optimal business processes and standards within the department to ensure important levels of customer support and to achieve high quality submissions.
- Contributes to the creation, and implementation of internal process and standards documents relating to publishing and publishing deliverables.
Regulatory Affairs Associate, bareMinerals / Buxom / Laura Mercier - bareMinerals / Buxom – Shiseido / Orveon - NJ
(2021-02 - 2022-08)
- Developed and maintained regulatory strategies for products in development, which included risk management plans, post-marketing requirements, labeling changes, and other related activities.
- Managed interaction with external agencies such as EMEA/ Health Canada/CFDA etc., managed internal cross functional teams to make sure on timely responses to agency for questions and concerns.
- Reviewed and Approved Artworks for all three brands which includes interaction with Product developments team and marketing team.
- Attended IBA conformance for 3 days regarding beauty brands which included new regulations for all new beaty products.
- Supported the preparation of documents, AW, Specs and many more statements for China Buxom launched and participated into China regulation calls every week.
- Worked with management to ensure rapid and timely approval of new products and continued regulatory support of marketed products.
- Worked on MECCA project to gather all AWs and documents for the new products.
- Introduces regulatory methods/procedures that are new for the organization. Apply advanced regulatory process principles to multiple tasks.
- Worked on registration project to get the Buxom product registered in different countries and helped the China regulatory team to launch the Buxom product in China.
Regulatory Affairs Associate, Lysol team - Reckitt Benckiser - Parsippany, NJ
(2020-03 - 2020-12)
- Provide registration and regulatory compliance of locally marketed products to bring competitive advantage to brands.
- Partner with QA on important products to ensure a U.S. regulatory compliance check was completed.
- Research and interpret new and modified federal, state, and local regulations to determine the impact on Reckitt Benckiser products.
- Provide reviews, comments and approval of all products labels/labeling, observance to existing products product registrations, and harmonization with other labels for Federal and State regulatory compliance.
- Recommend actions and alternatives to address issues raised by regulatory authorities.
- Recommend and provide alternative label language to address any non-compliance issues.
- Submitting all the reviewed labels into the state and the EPA for approval.
- Manage all regulatory requirements and documentation for regional regulations, such as VOC compliance, TSCA and DSL, Phosphate, etc.
- Provide support and documentation to the Regional Regulatory Network as requested.
- Prepare and update regulatory procedures like SOPs and Work Instructions.
- Serve as the key regulatory contact within a marketing sub-category.
Lab Technician Operation (OPS) in Manufacturing - Roche diagnostic system - Branchburg, NJ
(2018-07 - 2020-03)
- Performed bulk production and production support duties for Operations with dispensing and issuing more than 5000 batch records a year to help in proper diagnostic which also include the COVID-19 diagnostic Kit that very first made by Roche in the USA.
- Evaluate CMC supporting documents such as GMP certificates, Manufacturing Authorization, CoA, and request these documents from the appropriate associates as needed.
- Performed a variety of duties relating to production operations. Follows departmental work instructions, SOP's, OSHA safety regulations and cGMPs to perform assigned tasks.
- Monitor the lab supply inventory, generate expense purchase requisitions, input production data and other work-output data into SAP, and maintain documentation in accordance with established procedures and handling of hazardous materials in daily activities.
- Reviewed and filled all the batch records after dispensing. Maintain stock rooms and laboratories areas properly stocked with daily supplies to fulfil the routine.
- Check the Quality and compliance before going into the lab for each batch record. Manage schedules, workload and establish priorities using SAP input, as per internal customer needs.
Pharmacy Technician - Ultra-Care Pharmacy - Jersey City, NJ
(2016-01 - 2018-07)
- Prepared labels and filled prescriptions, accordingly, pre-packaging common medications that resulted in 25% faster order completion.
- Trained new pharmacy technicians, ensuring customer service standards were improved by 29%
- Provided outstanding customer service, building reports that drove client retention by 35%
- Assisted in transferring entire patient database to new system, swiftly learning use of new system, and serving as Lead Trainer for staff.
- Answering phone calls and responding to patients' queries
Capstone Project for Master's in Regulatory affairs - Northeastern University
(2022-05 - 2022-07)
- Worked on the XN project for Final semester which included FDA meeting requirements for medical devices and 510K submission for procedure for medical devices.
- Interacted with sponsor in Greece for Blood pressure machine and gathered all the documents and data for 510K submission and helped sponsor to arrange the FDA meeting.
