260 Job openings found

Role: • Preparation and review of Electronic Common Technical Document (eCTD), PSUR. PADER or RMP in compliance with EU and US standards and protocols. • Write, edit clinical study protocols. clinical study reports, summary documents, investigator brochures, portions of regulatory briefing documents and development safety update reports. • Drafting and revising pre-clinical summaries. • ...

  Minimum 20 years in Quality Assurance/Quality Systems in API/pharmaceutical manufacturing, with significant exposure to regulated markets To provide strategic and operational leadership to the Quality function, ensuring robust implementation of quality systems, compliance with global regulatory requirements, and continuous improvement in all quality-related processes for API manufacturing. Key Responsibilities Quality Systems & Compliance Implement, ...

Job Profile for QA/RA :  2 -3 Years of Experience ? Experience to prepare and review the documentation required for the ISO 9001:2015,EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745,IMDR 2017.? Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s,Change Control, Deviation, CAPA, Incident, and ...

Role Summary The Head – Legal, Environment & Land is responsible for ensuring full compliance with legal, environmental, and land-related statutory requirements. The role oversees all litigation and dispute-resolution matters, manages land assets and acquisition activities, and ensures adherence to environmental norms and regulatory guidelines. The position also provides leadership to ...

The job description is as below: The R&D Manager - NDDS will lead formulation and development of novel drug delivery systems, from concept to scale up and tech transfer, ensuring compliance with regulatory and quality standards and alignment with business goals. The role requires strong scientific depth in NDDS, team leadership ...

The key responsibilities would include the following: Reviewing select credit proposals which goes into Credit Committee (Level E2) and bringing out any regulatory inconsistencies. Reviewing credit related Policies, processes and notes. It involves giving feedbacks and advice to ensure the bank processes are comprehensive and compliant with regulatory guidelines. Supporting business/credit function of ...

Job Description   -Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US) -Hand on experience in preparation of CTD section as per regulatory requirements of different region -Having experience in preparation of query response and PAS, CBE and annual report. -Have ability to co-ordinate with ...

Job Title: Production Head - Pharma Pellet Manufacturing Facility Location: SB Organics, Chandapur Village, Hathnoora Mandal, Sangareddy District, Telangana Company Overview:SB Organics is a WHO-GMP accredited pharmaceutical pellet manufacturing facility dedicated to producinghigh-quality medicines. We are committed to adhering to the highest standards in manufacturing, ensuring the safety,efficacy, and compliance of our ...

  The key responsibilities would include the following: Reviewing select credit proposals which goes into Credit Committee (Level E2) and bringing out any regulatory inconsistencies. Reviewing credit related Policies, processes and notes. It involves giving feedbacks and advice to ensure the bank processes are comprehensive and compliant with regulatory guidelines. Supporting business/credit function of ...

Position:        Sr. Manager - QC  Location:        Ahmedabad Experience:    12 - 18 Years Industries:     Pharma   Responsibilities:         Lead and oversee the entire Quality Control department operations. Ensure compliance with cGMP, regulatory guidelines, and company quality standards. Review and approve analytical methods, specifications, and validation protocols. Supervise raw material, in-process, and ...