Senior Officer-Regulatory Affairs

Regulatory Affairs Specialist - CMC Variations/Submissions12 month contract - Immediate startOverview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes.Key Responsibilities:CMC Change Control Assessment:...

Regulatory Affairs Specialist - CMC Variations/Submissions 12 month contract - Immediate start Overview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes. Key Responsibilities: CMC Change Control...

Job Description We are seeking a Regulatory Affairs Specialist to support a leading medical device company in Ithaca, NY.  This is an onsite role open to local candidates.  Job Summary: This position will support worldwide regulatory registrations for our current and future medical devices as well as support process compliance in conjunction with our...

Job Description Regulatory Affairs Manager (European Union expertise)Medical Device Company. Tucson, AZOnsite (relo over time) 140k Talentry is looking for a Regulatory Affairs expert with medical device experience in the European Union (EM MDR).  This expert will aid in the preparation of documentation, submissions, applications, responses, adverse...

Senior / Labelling Specialist Job Description: We are seeking a highly skilled and experienced Senior Labelling Specialist to join our team and take on a pivotal role in the development and approval of labelling documents for our vaccine portfolio. As a Senior Labeling Specialist, you will be responsible for overseeing all aspects of labeling, from initial...

Senior / Labelling SpecialistJob Description:We are seeking a highly skilled and experienced Senior Labelling Specialist to join our team and take on a pivotal role in the development and approval of labelling documents for our vaccine portfolio. As a Senior Labeling Specialist, you will be responsible for overseeing all aspects of labeling, from initial...

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...

**Role/ Job Title**: Regulatory Escalation Officer **Function/ Department**: Grievance Redressal **Job Purpose**: Provide adequate & quick resolution to all the escalated complaints from regulatory bodies, senior managers, nodal offices and internal departments at GRD **Roles & Responsibilities**: Ensure adherence to grievances redressal policy and...

Job Description Position Overview: The Director, State Affairs (Western Region) plays a critical role in coordinating state affairs initiatives and managing state lobbying activities in assigned region(s) on behalf of the organization. This involves coordinating efforts among association members, national, state, and local trade associations, as well as...

Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic...

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...

Qualifications : B.Pharm/ M. Pharm/ M.Sc. Location: For two years in Brazil Office followed by Office in Mumbai Job description Responsibilities Ensure change management, post approval changes to ANVISA Review of technical documents for new submissions, post approval changes (Individual Protocol, HMP). Writing PATE for post approval changes Respond to...

Job Description Responsibilities: QA Officer: Execute quality assurance activities as per standard operating procedures (SOPs) and regulatory requirements.Conduct routine inspections and audits of manufacturing processes, facilities, and documentation.Assist in the investigation of deviations, non-conformances, and customer complaints.Support in the...

Job Description We are seeking a qualified and experienced individual to join our production team in the role of Production Officer to Senior Executive for Dry Powdered Inhaler (DPI). The ideal candidate will be responsible for overseeing the manufacturing processes related to DPI products, ensuring compliance with regulatory standards, and maintaining...

Position Overview: We are seeking a dynamic and experienced Manager International Business to join our pharmaceutical company. The ideal candidate will be responsible for overseeing international business operations, focusing on tender handling, B2B sales, and distributor network expansion. The role demands strong leadership, strategic thinking, and a deep...

Opportunity: The role holder will be directly responsible for the following: Management of a complete and consistent traceability data model framework for in scope regulatory returns including system changes and enhancements, thereby, ensure data integrity across the return. Govern delivery through KPIs and other design standards as agreed in the framework...

Job Description Healthcare Quality & Regulatory Compliance Specialist (Hybrid) AMEAOpportunity: Play a critical role in driving compliance and quality programs for Healthcare Transportation and facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer...

Job Description Role Description This is a full-time on-site role for a Senior Business Analyst encompassing Management Consulting responsibilities such as analyzing complex business problems, identifying improvement opportunities, and providing strategic recommendations to clients. The experience needed for this role is 3 years or more as a business...

Job Description Consultant en réglementation - CosmétiquesResponsabilités : - Révision réglementaire et approbation de l'étiquetage des produits pour les cosmétiques et d'autres classes non-OTC (par exemple l'hygiène féminine) pour le portefeuille de la société dans l'UE, le Royaume-Uni et l'EMEA.- Examen réglementaire et approbation de la...

Job Description BMC is looking for a classified legal officer to join its legal affairs department. The legal officer's main responsibilities includes, but not limited to:Drafting/reviewing legal documents, letters, and contracts and monitors legal obligations to ensure compliance.Maintains records and files of all legal cases and paperwork.Assist in...