Regulatory Affairs Manager

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...

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:...

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...

Provide regulatory support to customers/ internal teams and assist in maintaining regulatory requirements at all levels Coordinate for acquiring / renewal of FDA/FSSAI licenses, product approvals, chemist intimations/ approvals, maintain regulatory documentation and follow up on any Corrective action directed by the FDA officials Coordinate with Global...

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...

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...

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...

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...

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...

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...

JOB DESCRIPTION Executive - Corporate Affairs ·        To assist Assistant Manager – Corporate Affairs in matters related to VIP Travel o  Build relationship with various VIP passengers and their protocols o  Understand the travel requirements of VIP passengers and facilitate them accordingly o  Interaction with AOCS / Cargo staff...

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...

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 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 We are seeking a highly skilled and experienced Energy Regulatory Lawyer to join one of our esteemed legal clients. As an Energy Regulatory Lawyer, you will play a key role in ensuring compliance with energy regulations and advocating for our company's interests in regulatory proceedings. You will be responsible for providing legal advice and...

Job Responsibilities Conduct and execute all pharmacovigilance related activities in Unichem lab. Train PV Team, corporate office, manufacturing plants and other vendors as applicable in timely manner. Ensure preparation and maintenance of pharmacovigilance documentation and SOPs and train relevant stake holders. Train the PV team to prepare periodic safety...

Responsibilities Coordinating with all stakeholders for setting up a university, including but not limited to the following: Develop a comprehensive roadmap to setup a university, outlining key milestones, timelines, and resource requirements. Conduct feasibility studies and market analysis to identify academic programs and competitive positioning....

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...

**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...

Key Skills: MedWatch reports 21CFR Part 803 Regulatory Reporting Adverse events Product problems Complaint management Assess complaints