Regulatory Affairs Specialist – CMC 215

Specific activities and responsibilities: Review the drug product dossier section ( specifically 3.2.P.2 and 3.2.P.3 ) as per the EU regulatory requirement. Aware of regulatory requirements, and technical knowledge of various pharmaceutical dosage forms. Project coordination and management skills CMC regulatory requirements for other than...

Job Description Preferred qualifications are: • Experience in manufacture, quality or distribution in Pharmaceutical/Biotech industry • Strong oral and written communication skills in English and Spanish • Proficiency working with teams at different levels• Able to operate in a fast paced, dynamic environmentResponsibilities • Support site...

(JOINING ASAP) We are seeking for a Regulatory Affairs Specialist who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub:About usResponsibilitiesTo contribute to the production of client administrative documents and reports to be included in regulatory submissionsCompile, or supervise the compilation of...

(JOINING ASAP) We are seeking for a Regulatory Affairs Specialist who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub: About us Responsibilities To contribute to the production of client administrative documents and reports to be included in regulatory submissions Compile, or supervise the compilation of...

(JOINING ASAP) We are seeking for a Regulatory Affairs Specialist who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub: About us Responsibilities To contribute to the production of client administrative documents and reports to be included in regulatory submissions Compile, or supervise the compilation of...

(JOINING ASAP) We are seeking for a Regulatory Affairs Specialist who will be responsible for ensuring the delivery of regulatory activities performed in the platform/hub:About usResponsibilitiesTo contribute to the production of client administrative documents and reports to be included in regulatory submissionsCompile, or supervise the compilation of...

Job Description Preferred qualifications are: • Experience in manufacture, quality or distribution in Pharmaceutical/Biotech industry • Strong oral and written communication skills in English and Spanish • Proficiency working with teams at different levels• Able to operate in a fast paced, dynamic environmentResponsibilities • Support site...

MAIN RESPONSIBILITIES Provide technical support (internally and during meetings with prospects) and content for the preparation of proposals Represent the company in forums and conferences where he/she acts as an expert on a subject Prepare or review CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files). Define...

MAIN RESPONSIBILITIES Provide technical support (internally and during meetings with prospects) and content for the preparation of proposals Represent the company in forums and conferences where he/she acts as an expert on a subject Prepare or review CMC regulatory documents (full Module 3, Quality Overall Summary, IMPD, variation files). ...

Job Description Sr. Associate Regulatory Affairs with experience in manufacture, quality, or distribution in Pharmaceutical or Biotech Industry.Responsibilities: Assist RA CMC Site Regulatory to support regulatory activities (e.g. Facility registrations, variations/supplements, country specific documents coordination).Provide and maintain CTA/MA...

Job Description Sr. Associate Regulatory Affairs with experience in manufacture, quality, or distribution in Pharmaceutical or Biotech Industry.Responsibilities: Assist RA CMC Site Regulatory to support regulatory activities (e.g. Facility registrations, variations/supplements, country specific documents coordination).Provide and maintain CTA/MA...

Sunrise Remedies Job Opening for Regulatory Affairs (RA). **Experience**: Minimum 2 Years **Industries**: Pharmaceutical Company **Education**: B.Sc. / M.Sc / B.Pharm / M.Pharm **Job Location**: Santej Ahmedabad. **Key Responsibilities**: - Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices,...

We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team. Positions are: Executive / Sr. Executive / Asst. Manager - Regulatory Affairs Experience: 3 to 9 years Location: Andheri east, Mumbai Working Days: 6 days (Mon-Sat) - WFO Responsibilities: 1. Dossier...

We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team. Positions are: Executive / Sr. Executive / Asst. Manager - Regulatory Affairs Experience: 3 to 9 years Location: Andheri east, Mumbai Working Days: 6 days (Mon-Sat) - WFO Responsibilities: 1. Dossier...

Description Collate and review CMC documents (i.e. Master Formula Card, PDR, BMR, BPR, Specifications, Validation reports etc.) from F&D, ADL, QA, production, packaging department and review of data for ANDA preparation, deficiency response, annual reports and supplements. Prepare and review the ANDA’s sections. Compile controlled...

Job Purpose: The position will be overseeing Chemistry, Manufacturing, and Controls (CMC) activities, ensuring the highest quality and compliance standards. Responsibilities will encompass a range of tasks, including technical writing, collaboration with manufacturing sites, and close coordination with Quality Assurance (QA) and Quality Control (QC)...

Your Job Support EU Hub Manager for medicinal products submissions (new marketing authorization application, renewal, variations, MAH transfer)· Coordinate with EU local RA team and support Hub Manager for any regional and local EU requests· Coordination with project teams with internal and external staff and global partners incl. reporting...

Job Description Westerman is a leading firm of high-value intelligent solutions in the area of executive search whose work philosophy is based on the combination of the boutique model of international headhunting with a strong digital approach based on e-searching.We collaborate with a company in the pharmaceutical sector with an international presence in...

Key Deliverables Dossier compilation of initial MAA for Europe Market Response to EU authorities deficiency Scientific Advice Variations and Supplements (Type IA, IA, Type IB Type Timely review of technical and regulatory documents i.e. Specifications, batch records, method validation documents, Stability data, container closure system, DMF review. Hands...

Organisation : USV, a top -15 pharmaceutical company in India, excels in the diabetes and cardio sectors. With a presence in over 65 countries, our dynamic team of over 7,000 spans generations. Our commitment to brand building is evident in our popular products like Glycomet GP, Ecosprin AV, Jalra, Tazloc, Glynase and more. Responsibilities: For the CMC RA...