Regulatory Affairs Specialist
Sandoz
Bucharest, Romania
MAIN RESPONSIBILITIES
- Provide successful strategies for registration of the Sandoz products; ensure a country specific regulatory strategy for each product; ensure on time approval of procedures in progress in order to avoid launch delay;
- Prepare/submit variations to support post-submission/pre-launch changes for national or EU products; ensure all variations are prepared and submitted in concordance with national and European regulations; ensure professional planning and tracking of changes & execution of variations/amendments in the smartest, i.e. effective, fast and cheap way;
- Assist in solving any deficiencies raised by the authorities on request of RCC;
- Prepare and ensure submission of product registration dossiers; ensure new molecules submissions are executed according to the agreed business plan; support for fast and efficient regulatory process;
- Ensure timely renewal of marketing authorizations by national European procedure;
- Prepare and submit documentation for Marketing Authorisation transfer;
- Prepare and submit documentation for the registration or notification of food supplements and medical devices;
- Ensure regulatory compliance for all products marketed;
- Artworks preparation & tracking for packaging materials (PPM);
- Implement the changes from the variation approvals with impact on the packaging materials according to national regulations;
- Prepare Deficiency letters answers for Romanian Authorities in cooperation with RCC and ensure timely closing of commitments;
- Submit within European procedures national documents translations of SmPC, leaflet, labeling, mock-ups for EU procedures within 5 days after closing of the procedure;
- Provide to RCC requested country specific information on products/local regulations, translations or other requested documents/reports;
- Submit Export Declarations for the S.C. Sandoz S.R.L. products to the HA and close interact with Authorities in order to accelerate their approval;
- Survey and monitor national regulatory regulations and provide update to Global RA Departments;
- Submit OMS Certificates for different products in cooperation with RCCs;
- Perform Compliance Check for the products in the portfolio;
- Set up, implement and update local procedures to ensure compliance with Global procedures and national requirements;
- Ensure recording and tracking of all regulatory relevant documents;
- Management and maintenance of all local relevant regulatory databases (e.g. RegDB);
- Prepare the PLC (pre-launch check list) for LSM (Launch Supply Management);
- Ensure the conversion of the registration dossiers to eCTD;
- Proactively collaborate with the Sandoz departments to implement the action plan and set working priorities.
Minimum requirements
Education
- Medicine/pharmacy/Chemistry/Biochemistry high education diploma or other post graduate.
Experience
- 2-3 years of experience in a similar position;
- Pharma industry.
Languages
- Business English - fluent, medical and pharmaceutical terminology.
Competencies
- Relevant technical knowledge;
- Analytical and problem-solving skills;
- Strong communication skills;
- Attention to detail;
- Ability to work under pressure and to strict deadlines;
- Curious, eager to learn new things;
- Open minded, innovative, willing to improve processes;
- Strong negotiation skills;
- Previous experience in preparing regulatory documents (both administrative and scientific);
- Previous experience in translating medical and pharmaceutical texts from/into English;
- Previous experience in preparing artworks and packaging materials.
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