PRIYANKA PALKAR

Regulatory Compliance for IVD products as per Medical Device Rule 2017.

- Communicate and align with line manager, business lead, and other stakeholders on the regulatory registration plan and strategy, and timely update on the status as well as the actions taken to address any delay or potential
delay;
- Per regulations, timely register all the regulated products, and maintain the licenses, including new
registration, and changes;
 Communicate for the documentation required and support needed;
 Review the documents received, prepare local dossiers, and submit to local health authorities;
 Communicate with health authority for enquiries regarding the registration;
 File all the licenses/certificates; maintain and regularly update the license list;

- Ensure that the registration status is updated in SAP system;
- Ensure that the review and approve the promotion materials
- Review and evaluate the regulatory Changes/Trends, lead the actions to address the changes and
minimization the business impact;
- Escalate any major/critical and urgent regulatory compliance issue in timely manner, whenever applicable;
- Ensure that timely updation of global information on online repository;
- Ensure the post market surveillance as per local regulatory requirement;

gies to achieve targets.

- Registration Support to distributor market in export countries like Sri Lanka, Bangladesh, Nepal and
Maldives where ever applicable

• Supported department leadership in implementing new policies, procedures and controls.

Quality Compliance

• Negotiated contracts with vendors, securing favorable terms that benefited the organization''s bottom line.

Support to the quality team to maintain Quality Management System (QMS) and support during ISO 13485 Audits.

• Implemented robust data analysis practices to guide decision-making, enhancing product relevance and customer satisfaction.

People Development

• Reduced time to market for new releases by refining development pipelines and encouraging rapid prototyping.

-Provide clear direction and coaching to the team members, to ensure the whole team delivers good results and performs well.
- Manage performance evaluation of the direct reports in accordance with Ortho processes including:
- Developing goals and objectives; Frequent review of goals and objectives;
- Build up quality and regulatory capabilities within the team;
- Maintain a training system, to ensure all direct reports are well trained prior to performing any assignment
from quality and regulatory perspective;

• Developed strategic partnerships, expanding company's reach and facilitating entry into new markets.
• Identified areas in need of critical improvement and implemented strategies to achieve targets.

Collaboration & Team Work

• Established strong working relationships with clients through exceptional customer service and proactive communication efforts.

- Collaborate with all country/function leaders for continuously improvement on Quality and regulatory;
- Per business needs, support QA&RA in other countries in Asia region;
- Other assignments, whenever necessary

• Collaborated with cross-departmental teams in developing cohesive strategies aimed at achieving long-term organizational goals.

- Support in budget planning

• Coordinated with regulatory bodies to ensure compliance with industry standards, mitigating risk and safeguarding company's reputation.
• Optimized supply chain operations, forging strong supplier relationships to ensure timely and cost-effective delivery of materials.
• Collected, arranged, and input information into database system.
• Maintained database systems to track and analyze operational data.

ú Job Responsibilities:

Ø Communicate new regulatory requirements and changes within the organization.

Ø Manage and review overall documentation control and archival system,Registration certificates, under registration status and Dossier Planning.

Ø File all the documents, licenses/certificates; maintain and monthly update the license list.

Ø Escalate delay and potential delay to manager for action to minimize the impact on business.

ú Domestic activities:

Ø Responsible for domestic project submissions to national regulatory authority bodies. i.e. DCG(I), SFDA, zonal offices and WHO GMP Maharashtra..

Ø Applications for grant of manufacturing licenses for additional products and license renewals (Online application on FDA XLN Site).

Ø WHO GMP certificate/ COPP/ SLSPP/FSC. (Online application on FDA XLN website)

Ø Notification and approval of competent technical staff. (Online on FDA XLN Site)

Ø Layout approval & other domestic projects for e.g. tender certificates applications (MMC, NCC, PFC etc.) applications online.

Ø Preparation of Domestic applications for Grant of license to import for testing & analysis.

Ø Grant of license to manufacture for testing and analysis.

Ø Overseas site / Product Registrations in India and Commercial Import License.

Ø PSUR and Annual Product Notification filing.

Ø Follow up with state FDA, DCG(I) for approval status of various ongoing projects.

Ø Response to queries raised by various domestic regulatory bodies.

Ø Coordinate with R&D, QA, QC, Production & Packaging for technical documents required to get the faster response and justifications when required, in order to respond the queries raised by various regulatory authorities.

Ø Provide technical review of data & reports including Specification, Analytical Procedures, BMR and change Control needs to be incorporated in domestic fillings to assure scientific rigor, accuracy & clarity.

Ø Change control review and assessment and notification of post approval changes to DCGI as per CDSCO guidance document.

Ø Provided regulatory support in various audits by domestic regulatory authorities.

Ø Management of Internal audit, inspection, license renewal & registration records.

Ø Preparation of departmental SOPs and training records as and when required.

ú Export Activities:

Ø Compilation and Preparation of CTD/ACTD dossier, country specific registration dossiers for ROW countries.

Ø Handling of Non-regulated market including Latin American Countries, South East Asian Countries, CIS Countries and ROW countries.

Ø Gap Analysis of available data as per CTD requirements.

Ø Handling of Exports Tenders and Company registrations.

Ø Manage and review overall documentation control and archival system,Registration certificates, under registration status and Dossier Planning.

Ø Evaluation & solving of queries received from various drug authorities and responding them in a stipulated time period.

Ø Coordinate with R&D, QA, QC, Production and Packaging for technical documents required for compilation of registration dossiers.

Ø Checking & reviewing of technical documents like Analytical Method Validations, Process Validation, Finished Product Specification/Standard Testing Procedure, Certificate of analysis, legal documents like Certificate of Pharmaceutical Product, Free sale certificate etc.

Ø Checking for Artwork Development of Packing material for Product with respect to Product Approval.

Ø Maintaining & updating status of submitted and registered dossiers of various drug authorities along with query status.

Ø Provided regulatory support in various international audits.

ú Job Responsibilities

Preparation & Submission of Dossiers to the Indian Regulatory Authority (DCGI):

Ø New product applications as per Form 44 - Schedule Y (Formulations).

Ø Bioequivalence study NOC applications for Domestic & Export (Non-regulated) market as per DCGI guidelines.

Ø Clinical trial NOC applications & Submission of Clinical trial report for Domestic Market to Indian Regulatory Authority (DCGI).

Ø Import License applications (Form-12).

Ø NOC for Form-29 applications for Clinical trial Supplies/ Bioequivalence study supplies.

Ø Export NOC applications

Ø Applications for Post Marketing Surveillance studies (Phase IV).

Ø Toxicity study applications for API’s.

Ø DCGI query handling & timely submission of query response.

Ø Timely submission of Dossiers to the Indian Regulatory Authority (DCGI).

Ø Ensuring that a company's products comply with the regulations of the Indian Regulatory Authority (DCGI).

Ø Planning and developing product trials and interpreting trial data.

Ø Advising scientists and manufacturers on regulatory requirements.

Ø Package inserts Patient Information Leaflet & Therapeutic Rationale preparation & Review.

Bioequivalence studies (Export- Non-Regulated Market):

Ø Planning and sponsor side handling for bioequivalence studies of Domestic and Export (Non-regulated) market and their timely submission to the Indian Regulatory Authority DCGI/ Export Dept.

Ø Bioequivalence study monitoring.

Preparation of Standard Operating Procedures:

Ø For dossiers for the Indian Regulatory Authority (DCGI)

Ø For Bioequivalence study handling and monitoring Domestic & Export (Non-regulated)

Ø For Toxicity study handling.

Ø For Package inserts, Patient Information Leaflet & Therapeutic Rationale

Ø For Soft copy and Hard copy Archival.

Training program attended:

Advanced course on Good Clinical Practice (GCP) by Bilcare Research Academy, Pune.

Post marketing Surveillance:

Conducted Post Marketing Surveillance studies for Osteoarthritis, Hypertension.