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3 Biopharmaceuticals Jobs

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0.0 - 4.0 years

0 - 0 Lacs

chennai

On-site

Job Description: About Achievers Spot Medical Coding is the Fastest-growing Profession in the Healthcare Industry Today. It is a Niche Specialization and the Demand for Trained and Certified Medical Coders is Increasing Exponentially and Bound to Increase in Upcoming Years, Especially in India. you have At Least a Diploma/degree in Any Field. this Role is Open to Fresh Graduates with Excellent English Communication Skills. you Pay Strong Attention to Details and are Capable of Delivering Top-quality Work you are Goal-oriented and Thrive in Fast-paced Environments maintains a Working Knowledge of Cpt-4, Icd-10-cm, and Icd-10-pcs Coding Principles, Governmental Regulations, Uhdds (uniform Hospital Discharge Data Set) Guidelines, Aha Coding Clinic Updates, and Third-party Requirements Regarding Coding and Documentation Guidelines Contact Us: HR SHANMUGAPRIYA 8072891550

Posted 12 hours ago

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0.0 - 4.0 years

0 - 0 Lacs

bangalore, bhubaneswar, tambaram

On-site

Medical Representative Responsibilities: send your resume directly to, info@bristolvitalityhospital.com Selling the company's medications to doctors, pharmacists, and other relevant healthcare professionals. Scheduling appointments with doctors, pharmacists, and other healthcare professionals to promote company medications. Developing an in-depth understanding of company medications. Building and maintaining good business relationships with customers to encourage repeat purchases. Following up on leads generated by the company. Preparing presentations for potential customers. Researching competitors medications and their respective market performances. Keeping abreast of new developments in the medical field to determine the effect of such developments on the company's business strategies.

Posted 15 hours ago

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15.0 - 18.0 years

40 - 45 Lacs

Bengaluru

Work from Office

QUALIFICATIONS Education: Advanced degree in Life Sciences, Pharmacy, or related field Experience: 15+ years in regulatory affairs, including 5+ years leading global teams in biopharmaceuticals. Proven track record in NDAs/BLAs for novel therapies (ophthalmology/metabolic disorders preferred). Expertise in FDA/EMA interactions, including Pre-NDA meetings and Advisory Committees. Skills: Proficiency in clinical trial design, statistical analysis, and regulatory writing. Familiarity with eQMS tools (Veeva, TrackWise) and regulatory intelligence platforms. Global Regulatory Strategy & Submissions Develop and execute regulatory strategies for novel biologics, including pre-IND meetings, orphan drug designations, and accelerated approvals. Lead NDA/MAA submissions for US FDA, EMA, and other agencies, ensuring compliance with ICH guidelines and regional requirements. Oversee clinical trial applications (CTAs/INDs) and provide input on study design, endpoints, and risk mitigation. Team Leadership & Cross-Functional Collaboration Manage a global team of regulatory professionals, fostering expertise in biologics, ophthalmology, and metabolic disorders. Partner with R&D, Clinical Development, and CMC teams to align regulatory plans with development milestones. Compliance & Audit Management Ensure adherence to GCP, GMP, and 21 CFR Part 11 standards during regulatory inspections and audits. Maintain submission timelines using eCTD formats and electronic submission gateways Team & Project Management Mentor QA leaders across sites, fostering a culture of quality and accountability. Design training programs on GMP/GLP updates, inspection readiness, and root cause analysis methodologies. Post-Marketing & Lifecycle Management Direct post-approval regulatory activities, including variations, renewals, and safety updates. Monitor evolving regulations (e.g., FDAs Novel Drug Approvals guidance) and implement proactive compliance measures.

Posted 1 month ago

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