Biologicals Jobs – Apply to Latest Biologicals Job Vacancies

2 - 7 years

5 - 10 Lacs

Hyderabad

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Position Title: Scientific Writer Team: Regulatory Science Operations Job Type: Contract Job Location: Hyderabad (Hybrid) Job Description This is an exciting opportunity for a highly motivated individual to join Regulatory Science as a Scientific Writer and to be part of the Regulatory Sciences Operations team. The Scientific Writing Team drafts study reports and study summaries to support regulatory submissions for both biotech and crop protection products. This role will have a high emphasis on analytical chemistry. Scientific Writers collaborate closely with stakeholders and customers including Study Directors and Monitors, Subject Matter Experts, Quality Assurance, Statisticians, and Global Registration Teams. Job Summary Draft high-quality study reports and study summaries to support regulatory submissions for both biotech and crop protection products (this role work with analytical chemistry reports primarily). Strong scientific writing skills and a background in science (specifically analytical chemistry) is needed for drafting reports. Perform quality control reviews on draft reports and/or raw data. An understanding of Good Laboratory Practice (GLP) is required. Develop new report templates, optimize processes, and assess stakeholder feedback for continuous improvement. Coordinate peer reviews and Quality Assurance audits, collate comments, and facilitate finalization of reports and audit responses. Communicate effectively with key stakeholders and customers. Partnership with stakeholders and customers to understand regulatory reporting requirements is important for success. Job Qualification MSc (with knowledge in chemistry, biochemistry, or analytical chemistry); industry experience is preferred. Other degrees may be considered if proficiency in critical skills is demonstrated. Hands-on experience in different HPLC (or analytical) techniques, Interpret the test results with high accuracy from the raw data. Knowledge on writing protocols/ reports based on study (HPLC or other analytical test) findings. 2 to 7 years of relevant experience The ideal candidate will have experience in analytical chemistry Highly proficient in English, both spoken and written. Excellent verbal communication skills, which includes the ability to work effectively in a team environment. Excellent written communication skills, which includes strong keyboard and data entry skills and strong knowledge of Microsoft Word, Excel, Outlook, and Adobe Acrobat. Excellent attention to detail and ability to work on several projects simultaneously, efficiently, and independently. Excellent interpersonal skills with the ability to interact with a diverse set of stakeholders. Ability to work a partially-modified schedule to ensure overlap with our US-based teams, facilitating real-time collaboration and communication during key business hours.

Posted 3 months ago

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Manager, Regulatory Affairs (Biologicals) CIEL HR

9 - 12 years

11 - 15 Lacs

Ahmedabad

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Key Responsibilities: Regulatory Strategy Development: Collaborate with cross-functional teams to develop and execute regulatory strategies for biological products, ensuring alignment with corporate objectives and regulatory guidelines. Regulatory Submissions: Prepare and submit regulatory documents, including CDSCO dossiers/queries, variations including scale-up changes, and annual reports, while ensuring accuracy, completeness, and timeliness. Regulatory Intelligence: Monitor and interpret regulatory requirements, guidelines, and trends related to biological products to inform decision-making and maintain compliance. Cross-functional Collaboration: Work closely with R&D, Clinical Development, Quality Assurance, and Manufacturing teams to support regulatory activities, resolve regulatory issues, and facilitate product development and registration. Regulatory Compliance: Ensure compliance with applicable regulations and guidelines, including those set forth by regulatory authorities such as the CDSCO, FDA, EMA, and other global agencies, throughout the product lifecycle. Regulatory Agency Interactions: Serve as a primary point of contact for regulatory agencies, participating in meetings, teleconferences, and regulatory inspections as needed to address inquiries and facilitate approvals. Product Labelling and Promotional Material Review: Review and approve product labelling, promotional materials, and advertising to ensure compliance with regulatory requirements and company policies. Regulatory Document Management: Maintain regulatory files and documentation in accordance with company procedures and regulatory standards, ensuring accessibility and traceability. Interested candidates can share CVS at sheetal.c@cielhr.com

Posted 3 months ago

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