Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).
Post : Jr Professional
Job Description
The regulatory RA professional’s main function is to plan, prepare and submit high quality files to the authorities achieving fast approvals for products within the department area of responsibility. More specifically the regulatory professional has the following responsibilities with specific focus on the CMC documentation:
- Responsible for planning, coordination and executing the regulatory tasks as required in the projects or existing products in accordance with the regulatory strategy for the defined area of responsibility
- Responsible for preparation and compilation of the individual sections of all files for the defined area of responsibility, in accordance with internal requirements and external regulatory guidelines and regulations.
- Facilitates approval of all files for the defined area of responsibility
- Responsible for the regulatory interaction concerning scientific issues with affiliates and authorities for all files within the defined area of responsibility
- Responsible for updating or maintaining files within the defined area of responsibility, including evaluation of the regulatory implications of changes and necessary actions
Planning and co-ordination
Prepares and maintains regulatory submission plans for variations and similar in line with the regulatory plans
Coordinates and aligns activities with other RA departments, and Novo Nordisk units such as DAPI/DFP/Devices
Supports relevant NN units i.e. Manufacturing Development, Devices and Supply Chain Management, Product Supply and Quality Assurance with regulatory intelligence
Product/Project responsibility
- Compiles, submits and maintains all files for NN products/projects as agreed with manager according to the regulatory plan and in collaboration with stakeholders in primarily CMC and Product Supply. Prepares files of high quality that are easy to assess.
- Facilitates the approval process by identifying key issues, interacting with regulatory authorities and ensuring timely, complete and high quality answers to authority questions
- Handles Change Request (CR)-cases within area of the department’s responsibility.
- Provide Regulatory input to NC’s.
- Compiles, reviews and submits pre-meeting packages for authority meetings, conducts rehearsals and participates in meetings
- Reviews Quality or Device protocols and reports within area of responsibility
- Assesses and reviews the appropriateness of scientific documentation for specific regulatory purposes
- Responsible for archiving and retrieving documentation in novoDOCS
- Provides support to other groups within area of responsibility.
- Consults Regional Partners, the Global Regulatory Team or affiliates on submission and Question/Answer issues
- Contacts and consults with global regulatory authorities including FDA and EMA/national agencies in accordance with line management
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Regulatory knowledge and Sharing of better practices
- Responsible for keeping up to date with current internal requirements and external guidelines and legislation within area of responsibility
- Responsible for acquiring and maintaining business understanding, including therapeutic and obtaining scientific knowledge (e.g. therapeutic, biotech or pharmaceutical knowledge) within Regulatory Development and Life Cycle Management within area of responsibility
- Responsible for following current trends within the regulatory area, and implementing learning from competitors and previous NN experiences in future practice
- Communicates better practices regarding strategies, filings, regulatory procedures and guidelines within area of responsibility
- Participates actively in RA Expert Groups
- Trains stakeholders in RA issues as appropriate
Additional Information:
Location: Karnataka
Education: M.Sc or Ph.d
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Regulatory Affairs
End Date: 20th April, 2017
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