Siddartha Karaya

Regulatory Affairs Specialist (Consultant) at Zwiers (2024 – 2026)

Ensure compliance with European and national (Benelux) regulatory requirements M1-M3 and PV
Coordinate and submit variations, renewals, and notifications for registered products & regulatory intelligence and guidance on evolving regulations and guidelines.
Review and approve labeling and artwork (Promotional materials) to meet regulatory and quality standards.
Maintain regulatory databases and documentation to ensure up-to-date records.
Act as a point of contact for health authorities and regulatory agencies.
Medical information/PMS

Regulatory affairs Specialist at Organon (2023-10 – 2024-06)

ad interim

Pharmaceutical CMS National follow up, submission of and national implementation. (BeNeLux)
Submit the national phase documents following completion of CP or DCP procedure and approve/release the new artworks
Translation of the PIL (SmPc PIL DHCP)
Timely preperation and submision of regulatory applications
Maintain up to date various regulatory databases
Ensuring product labeling approval and compliance

Regulatory affairs Associate at Reckitt (2022-09 – 2023-02)

ad interim

Pharmaceutical RMS National follow up, submission of withdrawals and national implementation. (BeNeLux)
Assesment of promotion materials and PIL to ensure that it is in accordance with the Geneesmiddelen Code.
Familiar with software programms like TDS, Veeva Promomats
Accesing promotional materials, ensuring that the claims are in line with the KOAGKAG and Dutch law.
Skills learn: IFCN baby formulation, IDMP, DADII CARA

Regulatory at Astellas Pharma BV (2021-08 – 2022-09)

ad interim

Pharmaceutical RMS/CP follow up, Parallel imports follow up, submission of withdrawals and national implementation.
Assesment of promotion materials and PIL to ensure that it is in accordance with the Geneesmiddelen Code.
Familiar with software programms like TVT, Veeva RIM, Veeva Vault, Trackwise.
Accesing promotional materials, ensuring that the claims are in line with the EPFIA and Dutch law.

Regulatory Affairs Officer at Aurobindo Pharma BV (2020-06 – 2021-09)

Pharmaceuticals: national/cms/rms submission follow up of all the submission along with updating the various databases which are needed in line with the regulations of the EMA/National MEB.
Coordinating with the various departments’ artwork, QA and to maintain compliance gap analysis, ASMF/DMF and cep
Food and health products assessing the artwork and checking the compliance with the latest national regulations
Medical devices – familiar with the regulations of MDR/MDD/IVDR now more acquainted with class I.

Regulatory Affairs Officer at Cure Support (2020-01 – 2020-06)

Responsible: Compiling and updating TDS &MSDS. Writing SOP’s and updating the old one.

Preparation of export documents free sale certificate, export COO, EUR-1 certificate, statements (DoC) needed for registration purposes.Updating several (Kosher/vegan) certificates of the raw material and the end products.
Assessing and approving labels and Mock-ups and IFU. Align with the several departments of the company and with the (foreign) regulatory counterparts.Helping out the costumers and other stakeholders with the documentation for registration purposes.
Novel Food project, consulting several experts for submitting,collecting the necessary data for the Skills acquired: MSDS, TDS, NWVA policies, GMP, MDD/MRR/PIF and regulation concerning Novelfoods.
Got familiar with several regulations (EC) regarding GMO/BSE/allergens/MDR/MDD/ Cosmetics/NovelFood EFSA.

Regulatory affairs Officer at CBG-MEB (2019-01 – 2019-12)

Data entry processing new submissions,all types of variations, renewals
Skills acquired: life cycle managment eCTD, ICH, EURS, Lifecycle management PSUSA,PSUR, ASMF/DMF/CEP, MDR IVDR national/CMS/RMS/EMEA procedures Art. 61, SmPC. Mock-ups.

Protocol Specialist at Practocol (2018-03 – 2018-12)

Digitalization of pediatric oncology chemotherapies along with summarizing these clinical protocols for medical professionals.
And overlook the medical content of the summaries made and hands on tasks.
Skills acquired: Scientific writing, consisted of summarizing aims of protocols for the health workers Interpreting and understanding pediatric oncological protocols Entering the correct data in a software program to eventually digitalize the protocol.

Ward council member at Wijkraad Overvecht (2018-01 – 2020-01)

volunteer

Key Responsible: Member and treasurer of the Ward Council concerned with the issues regarding social issues. Attending and participating in the monthly meetings where a present problem is discussed along with the stakeholders. Beside that advising the municipality of Utrecht about the current issues in the ward.
Skills acquired: Financial administration. Gained insights in the various policies and social projects of Utrecht. Communicating with the various stakeholders which are various levels and hold different positions.

Physician at IGMC Shimla and associated hospital (2013-08 – 2014-07)

Full functioning as a physician in the various departments rotationally.

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