Regulatory Affairs Specialist – CMC 215

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...

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). ...

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...

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...

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...

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...

DescriptionAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Director, Chemistry Manufacturing and Controls (CMC) (Director, CMC) to join our A-team (hybrid*/remote). As a...

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Director, Chemistry Manufacturing and Controls (CMC) (Director, CMC) to join our A-team (hybrid*/remote). As a Director, CMC at...

DescriptionAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Director, Chemistry Manufacturing and Controls (CMC) (Director, CMC) to join our A-team (hybrid*/remote). As a...

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...

Job Description: Role : Scientist  Reports to : Associate Director - CMC (Analytical) Location : Hyderabad, India Purpose of the Role : Work both as individual contributor and in collaboration with team to facilitate & drive timely achievement of CMC & R&D objectives, from CMC (Analytical) function. Qualification : Ph.D (preferred), M. Pharma/M.Sc in...

Job Description: Position : Assistant Scientist / Scientist - CMC (Formulation) Reporting to : Lead scientist/Associate Director -CMC Location : Hyderabad, India Education/Qualifications : M. Pharm/Ph.D from premier institute. Experience : At least 7-9 years of industrial research experience, in the field of formulation development for differentiated...

Job Description: Position: Assistant Scientist / Scientist - CMC (Formulation) - Injectables Reporting to: Lead scientist/Associate Director -CMC Location: Hyderabad, India Education/Qualifications: M. Pharm/Ph.D from premier institute. Experience: At least 7-9 years of industrial research experience, in the field of formulation development for...

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 Responsibilities and Requirement of a Temporary Regulatory Specialist This position is in product certification and technical documentation for HVAC compressors. This person will support the Product Regulatory staff to ensure our compliance records are properly updated and maintained. This will include reviewing test data,...

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...

Company Description Aryan Tiles is a leading manufacturer, exporter, and supplier of ceramic raw materials and granite stone processing. With office and factory locations in Delhi, Ahmedabad, Chandigarh, and Jhunjhunu, we cater to organized and unorganized tiles and sanitary manufacturers and distributors in India, South Asia, and West Asia. Our product...