Responsibilities: Technical Document Preparation: Lead the preparation, review, and submission of Technical documents/Dossiers (CTD/ACTD) for both Regulatory and Non-Regulatory Markets. eCTD Publishing: Proficiently handle the electronic regulatory submissions (eCTD), ensuring accuracy and compliance with regulatory standards. Submission Build Activities: Execute submission build activities, including creating inter-document links, conducting quality checks, validating compiled submissions, and ensuring timely dispatch. Collaboration with RA - Ops Team: Coordinate and engage with the Regulatory Affairs Operations team to facilitate on-time submissions and publishing tasks. Manufacturing Document Review: Review critical manufacturing documents such as MFC, BMR, process validation Protocol/report, stability protocol/report, sampling protocol, process validation protocol, and PDR. Response to Agency's Queries: Prepare and review responses to regulatory agencies' queries, ensuring timely submission within stipulated deadlines. Regulatory Submissions Development: Develop and deliver comprehensive regulatory submissions within agreed-upon timeframes, providing crucial regulatory support to project teams for assigned projects. Education: Bachelor's/Master's Degree (preferably in B Pharm/ M Pharm) or Any Life Science field. Experience: 2 - 4 years of hands-on experience within the CRO/Biotech/Biopharma industry. Demonstrated expertise in gap analysis, publishing, and knowledge of CTD compilation. Communication Skills: Excellent communication and interpersonal skills, both written and spoken, with the ability to effectively interact with sponsors and internal stakeholders at all levels.
Role and Responsibilities: The Lead - Strategic Business Development will play a crucial role in maintaining strong client relationships, handling clients, and acquiring new clients for our Business Development process. They will be responsible for positioning MakroCare's specialized services with strategic planning and implementation for medical devices and diagnostics companies in Europe and the USA. Additionally, the role involves developing and implementing business development strategies, maintaining international contacts, achieving sales targets, and working with the marketing and pre-sales teams for lead generation. Candidate Qualifications: Bachelor's Degree in any Life Science with an MBA/PGDM certification Minimum of 6 - 8 years of experience in the BA BE/CRO industry as a Business Development. Proven success and experience in regulatory projects within the Biotech/Life sciences/pharmaceutical environment Experience in international pharmaceutical projects with excellent communication skills Cooperative and assertive working style with the ability to understand and explain complex relationships Basic knowledge of data fields related to pharmaceutical products Required Skills: Business Development Strategy & Services Client Handling New Client Acquisition HealthCare, Medical Devices, Regulatory Affairs & Clinical Research
Education: Bachelors Degree in Life Sciences or related field Markets: US/UK/EU/ROW Job Summary: We are seeking a detail-oriented and proactive Associate - Regulatory Affairs (RA) Publishing with 1-3 years of experience in regulatory submissions across global markets including the US, UK, EU, and ROW (Rest of World). The ideal candidate will have a background in Life Sciences and possess hands-on experience with eCTD/aCTD submissions. This role is crucial for facilitating on-time submissions, executing submission build activities, and ensuring compliance with regulatory requirements. Key Responsibilities: Prepare, review, and compile regulatory submissions in eCTD/aCTD formats for various markets including the US, UK, EU, and ROW. Ensure submissions are compliant with the regulatory guidelines and are ready for on-time dispatch. Manage and track the status of submissions and respond to regulatory agencies' queries promptly and accurately. Prepare and review key regulatory documents including Master Formula Card (MFC), Batch Manufacturing Record (BMR), Stability Protocols/Reports, Sampling Protocols, and Process Validation Protocols/Reports. Collaborate with cross-functional teams to gather necessary information and ensure the accuracy and completeness of documentation. Conduct thorough quality checks and validations on compiled submissions to ensure they meet all regulatory and internal quality standards. Create inter-document links, and manage the integrity and accuracy of submission components. Execute submission build activities, including the generation and validation of final submission outputs. Manage the submission lifecycle, ensuring compliance with timelines and regulatory requirements. Support the publishing tasks, including the management of electronic and paper submissions. Facilitate communication with regulatory authorities to resolve queries and provide additional documentation as required. Assist in the preparation and submission of responses to regulatory agencies in a timely manner. Identify opportunities for process improvements in submission preparation and publishing. Stay updated with the latest regulatory requirements and best practices in submission management. Skills & Competencies: Proficient in eCTD/aCTD submission management. Strong knowledge of global regulatory guidelines (US, UK, EU, ROW). Experience in preparing and reviewing regulatory documents such as MFC, BMR, Stability Protocols/Reports, Sampling Protocols, Process Validation Protocols/Reports, and PDR. Excellent attention to detail with strong organizational and project management skills. Ability to work effectively in a team-oriented environment with cross-functional teams. Strong communication skills, both written and verbal. Proficient in MS Office Suite and regulatory publishing tools. Ability to manage multiple projects and prioritize tasks effectively.
Job Summary: We are seeking a skilled Research Analyst-I with a strong focus on Regulatory Affairs (Authorities/Bodies) to provide detailed product profiles, regulatory intelligence, and comprehensive data analysis. The ideal candidate will have experience in secondary research within the context of regulatory bodies, clinical trials, drug development, and clinical studies. This role requires expertise in gathering, evaluating, and analyzing scientific and legal data to stay updated on regulatory changes, aiding in drug and device development. Key Responsibilities: Secondary Research: Perform comprehensive secondary research to develop detailed profiles of drugs, medical devices, and clinical products. Data Compilation and Analysis: Collect and analyze data using modern and traditional research methods, organizing and synthesizing information from diverse sources. Document Analysis: Study scientific and legal documents to support product profiles and regulatory requirements. Information Management: Gather, evaluate, organize, and manage information from various formats including public reports, filings, clinical trial data, and company publications. Regulatory Compliance: Stay updated on changes in regulatory legislation and guidelines related to drugs, medical devices, and clinical studies. Data Analysis: Analyze complex scientific information, including clinical trial data, to provide insights into drug development and compliance. Labeling and Packaging: Outline requirements for the labeling, storage, and packaging of medical products to ensure compliance with regulatory standards. Intelligence Research: Conduct intelligence research on pharmaceutical and biotech companies, universities, and public organizations involved in drug research and development. Data Capture: Capture and update data on companies, clinical trials, and drug development from various sources including press releases, SEC filings, clinical trial reports, and scientific studies. Education and Requirements: Bachelors/Masters Degree in Life Sciences, Biotechnology, Pharmacy, or a related field. 1-2 Years of experience in secondary research with a focus on regulatory affairs. Proficiency in secondary research methods related to regulatory bodies, clinical trials, drug development, and clinical studies. Strong understanding of regulatory legislation and guidelines within the biotech and pharmaceutical industries. Familiarity with compiling and analyzing scientific data from public sources such as clinical trials, company reports, and NIH databases. Excellent analytical skills and the ability to handle and synthesize complex regulatory information. Skills Required: Strong secondary research skills, particularly in regulatory affairs. Ability to interpret and evaluate complex scientific and legal documents. Knowledge of drug development processes, clinical trials, and product compliance. Excellent written and verbal communication skills. Proficient in gathering and managing information from a variety of sources. High attention to detail and strong organizational skills. Ability to keep up with regulatory changes and trends in the pharmaceutical and biotechnology sectors. Preferred Experience: Previous experience working with regulatory bodies or authorities. Experience in analyzing clinical trial data and scientific reports.
Associate - Clinical Quality Assurance (CQA) Department: QA - MakroCare and DDi Job Roles and Responsibilities: Perform maintenance, review, and approval of company Standard Operating Procedures (SOPs) in compliance with ISO standards and applicable international and national regulations. Prepare and review Quality Management System (QMS) documents, CQA procedures, and assist in reviewing department SOPs as needed. Manage SOPs in mLMS, create users, review training records, and escalate non-compliance issues to the Head of CQA or relevant department heads. Maintain the CQA document repository and archive validation protocols and documents in line with regulatory requirements. Conduct internal audits of Clinical Research Department activities and ISO requirements, ensuring compliance with ICH-GCP and company procedures. Provide training to staff on ISO standards and local regulations when necessary. Control and manage documents, including maintaining master lists and issuing change controls, deviations, CAPAs, amendments, and notes to file. Update logs for change control, deviations, CAPAs, amendments, and NTFs. Prepare annual CQA reports and trend analysis, and assist with external audits from clients, certification bodies, or regulatory authorities. Requirements: Education: Bachelor's or Master's in Life Sciences (or related field). Experience: 2-3 years of experience in Clinical Quality Assurance or related roles. Familiarity with ISO regulations, ICH-GCP guidelines, and QMS. Experience in conducting internal audits and maintaining regulatory documentation. Note: Additional responsibilities may be assigned by the Head of Department (HOD).
Overview: The Proposal Analyst plays a crucial role in the clinical research organization by overseeing the development and submission of proposals for research projects. Their work is vital in securing funding and support for important clinical trials and studies. The Proposal Analyst collaborates with cross-functional teams, conducts in-depth analysis, and ensures compliance with regulatory requirements to create compelling proposals that align with the organization's research goals. Key Responsibilities: Manage the end-to-end process of proposal development for clinical research projects. Analyze and interpret RFP (Request for Proposal) requirements to tailor proposals accordingly. Collaborate with internal stakeholders to gather necessary data and insights for proposal creation. Ensure accuracy and completeness of proposal content and compliance with regulatory guidelines. Conduct comprehensive literature reviews to support proposal development. Develop and maintain proposal templates, systems, and databases. Contribute to the strategic planning and positioning of proposals. Coordinate and facilitate proposal review meetings and revisions. Track and report on proposal submissions and outcomes. Support the identification and pursuit of new funding opportunities. Participate in continuous improvement efforts to enhance proposal development processes. Stay updated on industry trends and best practices in clinical research proposal development. Provide training and guidance to team members on proposal development best practices. Participate in cross-functional teams for specific research initiatives. Ensure adherence to deadlines and milestones for proposal submissions. Required Qualifications: Bachelor's degree in a relevant field such as Life Sciences, Clinical Research, or related discipline. 2-6 years of experience in proposal development within the clinical research or healthcare industry. Demonstrated understanding of clinical research processes and regulations. Proficiency in data analysis and interpretation to support proposal development. Strong project management skills with the ability to handle multiple proposals simultaneously. Excellent written and verbal communication skills with attention to detail. Familiarity with regulatory compliance requirements for clinical research proposals. Ability to work effectively in cross-functional and collaborative team environments. Proficiency in using MS Office Suite and other relevant software for proposal development. Proven ability to work under pressure and meet tight deadlines. Strong organizational and time management skills. Ability to adapt to changing priorities and requirements in a dynamic research environment. Experience with grant applications and funding proposals is preferred. Knowledge of budget development and financial aspects of research proposals is a plus. Certification in clinical research or proposal development is advantageous.