Ability to develop key partnerships internally and externally, influence and negotiate with key personnel, and plan strategically with a systems thinking approach.
To plan and execute various development trials for the allocated project in formulation laboratory along with online recording of experiments and data compilation. To carry out stability studies of projects as per the project requirement and regulatory guidelines.
Regulatory Affairs Manager prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet company's and health authorities’ requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the licence management strategy and approach.
Exposure to antibiotics during a key developmental window in infancy can stunt the growth of insulin-producing cells in the pancreas and may boost risk of diabetes later in life, new research in mice suggests. The study, published this month in the journal Science, also pinpoints specific microorganisms that may help those critical cells proliferate in early life.
Researchers at the University of Cologne have discovered that mRNA-based COVID-19 vaccines have a persistent effect on the innate immune system. These mechanisms may help the human body to better protect itself against potential future infections / publication in Molecular Systems Biology
The U.S. Food and Drug Administration inspected Aspen Biopharma Labs Private Limited, drug facility; at Rangareddy region from September 16 to September 21, 2024. And they get a warning letter which summarizes significant deviations from Current Good Manufacturing Practice CGMP for active pharmaceutical ingredients.
Using video microscopy in the living mouse lung, UC San Francisco scientists have revealed that the lungs play a previously unrecognized role in blood production. As reported online March 22, 2017, in Nature, the researchers found that the lungs produced more than half of the platelets – blood components required for the clotting that stanches bleeding – in the mouse circulation.
Study Preparation and Regulatory Compliance, Site management. Documentation and Reporting, Adverse Event Management and Pharmacovigilance, Reporting suspected adverse drug reactions as per pharmacovigilance requirements, ensuring timely submission of SAE reports to ethics committees and regulatory authorities.
Ph.D., Masters degree, Bachelors Degree with First class in all the preceding degrees in the appropriate branch, with an exemplary academic record throughout.
Interested candidates are hereby informed to visit the website regularly for individual notifications, recruitment rules, general terms and conditions and instructions for applying and other details carefully before applying their application.
The minimum educational qualification of the candidate shall be Matriculate or equivalent followed by Diploma m Pharmacy from Govt, recognized Institute. Previous Experience of working as Pharmacist is desirable.
Senior Secondary with Science or its equivalent from a recognised University, Board. Degree in Pharmacy from a recognized institution, university. Should be a registered Pharmacist under the Pharmacy Act 1948.
Doctorate in Life Sciences or allied sciences from a recognized University with at least 10 years experience excluding the Ph.D. tenure, if any in at least 2-3 sectors including Industry, CRO, Technology Business Incubators, Start-ups, Innovation Management, or Academic, Research organizations.
Provides inputs for selection of the equipment Estimates the batch size based on available equipment at the receiving site. Assists in evaluating the suitability of partners development, manufacturing facility for technology transfer.
Responsible to monitors activities at clinical study sites to assure adherence to Good Clinical Practices GCPs, Standard Operating Procedures, and study protocols under supervision of Clinical Operations Manager, Clinical Research Specialist.
Compilation and review of product license applications, variations, and renewals for Mexico or ASEAN countries as per regulatory requirements respectively with minimal supervision. Manages electronic documents and creates electronic submissions in CTD format.
End to end case management, including case receipt, database entry, peer review and submission to applicable regulatory authorities within stipulated time. Perform and monitor literature for company molecules.
In addition to causing several types of cancer, human papillomavirus appears to bring a significantly increased risk of heart disease and coronary artery disease, according to a study being presented at the American College of Cardiology's Annual Scientific Session.