B.Sc

Filling machine Groninger, Optima, Dyno Truking filling and sealing machine, Bosch filling machine, Steam sterilizer Fedegree

The Regulatory Affairs Manager II is fully proficient in applying established standards and performs regulatory affairs management for moderately to highly complex international market submissions in all regions with minimal coaching. They are expected to facilitate strategic input, provide proactive contribution to submission planning, identify areas for continuous improvement, and lead cross-functional activities. They participate in the continuous improvement of processes and tools, systems.

Knowledge of regulatory guidelines applicable to formulation development. Must have handled ER, MR, Pellets drug products for US and EU market.

Data entry into CRF/eCRF and maintain a record of radiological investigations and other functional assessment data; Co-ordinate with Co-Is radiology, immunology and pathology, for the required inputs from them as per the protocol. aim to study the spectrum and prevalence of diffuse parenchymal lung diseases by developing a National ILD registry using multidisciplinary discussion, MDD to validate the diagnoses, along with probable etiologies, prognosis and quality of life assessment.

Exposure to OSD Manufacturing operations like Granulation, Compression, Coating, Pellet coating, Capsule filling, Primary Packing and Secondary Packing. Expertise in e-BPR and e-log will be added advantage.

Good knowledge of Tablet & Capsule, Coating, Granulation, Compression, Good command on QMS & Documentation, IPQA, Qualification. Having good knowledge for scale up, technology transfer and site transfer. Candidates currently in Production and QA may also explore career opportunity in FTT for faster professional growth.

Any Masters Degree B.E, B.Tech, B.Pharma, MBA, PGD in Management with at least 02 years of experience with having minimum 60% marks OR The candidate should either have a Bachelors degree in science, commerce with at least 03 years of experience with having minimum 60% marks may also attend.

He, she will be responsible for providing Therapeutic Area workstream leads with administrative support on pre-defined projects. The Project Manager will set and develop the operational aspects of the project, develop, and monitor timelines, milestones and project metrics and is responsible for managing the projects from an operational perspective from the development and initiation phases through implementation and completion within scope provided by Medical Directors who remains responsible and accountable for the project content.

Achieve and exceed the sales targets on a consistent basis through effective implementation of the sales promotion strategies and scientific initiatives. Constantly update the knowledge of disease and product area so as to facilitate scientific discussion with stakeholders to enhance productivity levels as expected by the Company.