MBBS BIOCON PLACEMENT
Role/Job Description for Clinical Regulatory – • Apply Clinical Pharmacology knowledge in Biologics Drug Development • Develop and apply medical education toward inputs toward Clinical Development strategy • Review /preparation of CTA and associated documents, CSR and annexures. etc. • Preparation of questions, presentations and company position for regulatory scientific advices (clinical &bioanalytical part), active participation during preparation and actual meeting with agencies • Preparation / Review of responses to clinical / bio-analytical questions received from regulatory agencies and partners / potential partners • Building the team of clinical regulatory associates and lead the team to successful submissions and approvals • Identification of clinical regulatory requirements for different products and support development and operations team Technical / Functional Skills • Good clinical understanding of Diabetes, Oncology and Autoimmune diseases • Expertise and experienceWill assist in preparation / review of clinical study protocols forr pharmacology studies, safety and efficacy studies • Preparation and review of clinical overall summary including the immunogenicity assessment • Good understanding Ability to understand clinical development of biosimilar products clinical development and efficacy guidance • Experience Assist in module -5 preparation and review as per eCTD requirements (would be preferred) • Good clinical understanding of Diabetes, Oncology and Autoimmune diseases • Hands on experience in partner and regulatory agency interactions / communications related to clinical regulatory topics Behavioural / Management / Other Skills: • Should be a good team player when interacting with CFT and partner teams • Should like reading and working on policySomeone who is a habitual reader. . • Strong communication skills written and oral. • Learning attitude . Qualification-MBBS.