Regulatory Affairs Specialist is responsible for ensuring that medical devices comply with all applicable regulations in India and international markets

M.Sc. in Chemistry, Chemical Sciences, Pharmaceutical Sciences or M.Pharm in Chemistry along with 2 years research experience 

First Class M.Pharm, MS (Pharm) Masters in Pharmacognosy or Bachelor of Ayurvedic Medicine and Surgery. PhD in Natural Product Chemistry, Life Sciences, Pharmaceutical Sciences or related disciplines. 

Graduation degree in Science B.Pharm., Life science, B.Sc., Bio-Tech, zoology, botany etc., with PG diploma in Clinical Research is mandatory.

Post Graduate Degree in Biotechnology, Biochemistry, Life Sciences, including the integrated PG degrees.

Bachelor Degree in Pharmacy from a recognized institution and registered as Pharmacist under the Pharmacy act 1948

First Class Masters Degree in Pharmacology, Life-Sciences from a recognized university. Experience in the Research field and scientific writing. Candidates with proficiency in computer application will be preferred.

knowledge of various sophisticated instrumental methods for qualitative and quantitative analysis of tissue engineered constructs and regenerative technology development for clinical translation.

M.Sc. in Botany Taxonomy, Molecular Biology and Biotechnology, Bioinformatics, Genomics, Plant Biotechnology.

M.Sc. in life sciences with NET / DBT-JRF / GATE or equivalent exam cleared. Minimum 60% marks in Masters or equivalent degree.

Clinical batch data review, method validation, and stability study evaluations as per cGMP & regulatory norms. Routine analysis of clinical samples and stability samples. 

Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.

Maintain effective relationship with the end stakeholders medical scientific community within the allocated Global Business Unit and product – with an end objective to develop education and communication content as per requirement

Support Cross-functional team like Analytical Development, Formulation Development during product development and align documentation as per HC guidelines and Extend support for any other Regulatory related Function.

Ensure team members are trained and competent in all delivery areas. Assist the team during high work volumes by completing LTO accountabilities. Apply scientific knowledge to create compelling medical content and communications.

Work closely with Senior director EBM strategic planning and operations, business partners, therapy areas lead, eBuy manager, external vendors

Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives 

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