10 Pmda Jobs

Job Title: Corporate QA Manager / Sr. Manager Department: Corporate Quality Assurance Preferred candidate profile Responsible for harmonizing Quality Systems across sites, ensuring regulatory compliance (USFDA, EMA, ICH Q7, EU GMP Part II), managing audits, and driving data integrity and continuous improvement across the organization. Key Responsibilities: Harmonize and oversee quality systems across all API manufacturing sites as per global GMP requirements. Maintain compliance with regulatory guidelines and support audit readiness. Conduct routine site inspections and manage external regulatory & customer audits. Review and approve validation documents, master documents, BMRs, and quality-...

As a senior regulatory executive at PopVax, your role will involve overseeing the end-to-end qualification of novel vaccines and biologics in the US through FDA processes. This includes managing the entire process from preclinical development to animal trials, GMP manufacturing, human trials (IND), and licensure (BLA). Your expertise in navigating the regulatory landscape will be crucial in ensuring successful approval and market entry for our innovative medicines. Key Responsibilities: - Lead the regulatory strategy and submission process for novel vaccines and biologics in the US, ensuring compliance with FDA requirements at every stage of development. - Collaborate with cross-functional t...

Role Overview: You will be leading the Quality and Regulatory department of the API and Intermediate business at LOXIM. Your primary focus will be on ensuring quality, compliance, and global regulatory excellence, with a hands-on approach. You are expected to align with cGMP, ICH, and international regulatory standards, strengthen systems, people, and culture. Your deep understanding of API and intermediate processes, global filing requirements, and ability to guide teams through audits, inspections, and technology transfers will be crucial. Key Responsibilities: - Lead QA, QC, Regulatory Affairs, and Compliance functions at all manufacturing sites. - Ensure alignment with cGMP, ICH Q7, and ...

Regulatory Affairs Hiring Profile eCTD Specialist Experience Level: 3 to 6 Years Location: Work from office (Hyderabad) Skills & Qualifications: 1.Education: Bachelor's or Masters degree in Life Sciences, Regulatory Affairs, or related field. 2.Experience: 3 to 6 years of experience in regulatory affairs with a focus on eCTD submissions, preferably in the pharmaceutical or biotechnology industry. Role Overview: With 3 to 6 years of experience in regulatory affairs, this role requires expertise in eCTD submission software, strong knowledge of global regulatory standards, and the ability to troubleshoot and improve submission processes. The specialist will ensure compliance with evolving regul...

Job Title: Biostatistical Programmer (SDTM & ADaM) Experience: 5+ years Employment Type: Full-time Location: Hyderabad/Bangalore/Delhi/remote Industry: Pharmaceuticals / Clinical Research / CRO Functional Area: Biostatistics / Programming / Clinical Data Management About the Role We are seeking a skilled Biostatistical Programmer with 57 years of experience and strong expertise in CDISC standards (SDTM & ADaM) . This role involves developing, validating, and maintaining datasets and statistical outputs to support clinical trial submissions. You will work closely with biostatisticians, data managers, and clinical teams to ensure high-quality deliverables aligned with global regulatory require...

PopVax, an Indian biotechnology company based in Hyderabad, with a primarily remote US subsidiary nominally located in New York, is seeking a senior regulatory executive. The company is funded through research agreements with the Gates Foundation and Vitalik Buterin's biosecurity company, Balvi. Over the past year, PopVax has been developing a novel second-generation mRNA platform for low-cost broadly-protective vaccines using computationally-driven antigen design. The primary focus is on an open-source booster vaccine candidate designed to provide protection against the entire sarbecovirus species and potentially the betacoronavirus genus, including current and future strains of SARS-CoV-2,...

Experienced QA person managing multiple projects involving implementation. Ensuring set norms & laws are met. Excellent knowledge of QA processes of risk management, clinical data management, electronic data management.

The candidate should be M.Sc. (Preferably Microbiology) / M.Pharm/Quality Assurance) with at least 10 /12 years of relevant experience in medical devices industry. IPQA, QMS, Validation, compliance , QA related to its processes and strategy.

Regulatory Affairs Hiring Profile eCTD Specialist Experience Level: 3 to 6 Years Location: Remote Skills & Qualifications: 1. Education: Bachelor's or Masters degree in Life Sciences, Regulatory Affairs, or related field. 2. Experience: 3 to 6 years of experience in regulatory affairs with a focus on eCTD submissions, preferably in the pharmaceutical or biotechnology industry. Role Overview: With 3 to 6 years of experience in regulatory affairs, this role requires expertise in eCTD submission software, strong knowledge of global regulatory standards, and the ability to troubleshoot and improve submission processes. The specialist will ensure compliance with evolving regulatory guidelines, pr...

Job title manager GMP (Good Manufacturing Practices) QA (Quality Assurance) Reports to Head of Quality Assurance (GMP and GCP) Job purpose Our Quality team is growing, and we are currently seeking a Manager of GMP QA Operations to play a pivotal role in ensuring the quality and compliance of our clinical and commercial manufacturing processes. Reporting to the Head of QA, the Manager will oversee a team responsible for manufacturing, batch record release, investigations, deviations, CAPAs (Corrective and Preventive Actions), change controls, analytical methods, stability programs, and auditing within our GMP operations. Duties and responsibilities QA managers define and implement quality sta...