Regulatory Affairs and Quality

2 weeks ago

United Kingdom PharmaGroww Full time

Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies. We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients.
JGL in India has Research & Development units at Noida and Mysore. It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively.
The manufacturing location at Mysore is spread over 69 acres and it’s a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide. The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin. The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA. Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore. R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids. All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services.
JGL’s full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market.
Revenue of Jubilant Pharma is constantly increasing and during the Financial Year 2018 -19 it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year 2017-18.
Authoring of Module 1 along with quality modules
Assessments of post approval changes, life-cycle maintenance and ensure timely post approval regulatory activities
Coordinate with cross-functional teams for desired regulatory data and accordingly plan & complete regulatory filing activities
Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends
Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner
Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements
Maintain regulatory files/database


#

  • Regulatory Specialist

    2 weeks ago

    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...

  • Regulatory Specialist

    2 weeks ago

    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...

  • Regulatory Specialist

    2 weeks ago

    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring,...

  • Regulatory Specialist

    2 weeks ago

    United Kingdom VRS Regulatory Full time

    Join the regulatory affairs team at a global pest control products company. Friendly and experienced team Work on compliance and registrations for a global portfolio of products. Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...

  • Regulatory Affairs Interim

    2 weeks ago

    United Kingdom CSR Group Full time

    Job Title: Regulatory Affairs Consultant (Cosmetics) Company Overview: A leading company we represent is pharmaceutical company specializing in cosmetics, committed to delivering high-quality and innovative products that enhance the beauty and well-being of our customers. We are seeking a talented Regulatory Affairs Consultant with expertise in cosmetics...

  • Regulatory Affairs Specialist

    4 weeks ago

    United Kingdom Corin Group Full time

    Corinium Centre, Love Lane Industrial Estate, Cirencester GL7 1YJ, UK Req #233 04 April 2024 Corin is seeking a Senior Regulatory Affairs Specialist to be responsible for product registration and all regulatory aspects of post-market surveillance. The Senior Regulatory Affairs Specialist will require extensive knowledge of all applicable standards,...

  • Regulatory Affairs and Quality

    3 weeks ago

    United Kingdom Syneos Health, Inc. Full time

    Senior Professional, Quality Management  Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...

  • Freelance Regulatory Affairs Consultant

    2 weeks ago

    United Kingdom RBW Consulting Full time

    UK Based Freelance EU IVD Regulatory Affairs Consultant RBW Consulting are working in partnership with a global mid-sized CRO in their search for a Freelance IVD Regulatory Affairs Consultant based in the EU to start as soon as possible within their IVD function. Local ethics committee submissions and Annex XIV submissions for clinical trial assay across...

  • Regulatory Affairs Specialist

    6 days ago

    United Kingdom Meet Recruitment Limited Full time

    Senior Consultant Specialising In Regulatory Affairs I am seeking a highly motivated and experienced Regulatory Affairs Specialist with expertise within OTC/Cosmetics experience to join us on a contracted basis for a period of 6 to 12 months. As a key member of the Regulatory Affairs team, you will play a crucial role in ensuring our products comply with...

  • Regulatory Affairs Specialist

    2 weeks ago

    United Kingdom Meet Recruitment Limited Full time

    Regulatory Affairs Specialist - Medical Device Job Title: Regulatory Affairs Specialist - Medical Device Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to...

  • Regulatory Affairs Specialist

    3 days ago

    United Kingdom Meet Recruitment Limited Full time

    Regulatory Affairs Specialist - Medical Device Job Title: Regulatory Affairs Specialist - Medical Device Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to...

  • Regulatory Affairs Specialist

    2 days ago

    United Kingdom Meet Recruitment Limited Full time

    Regulatory Affairs Specialist - Medical Device 2 weeks ago Be among the first 25 applicants Job Title: Regulatory Affairs Specialist - Medical Device Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance...

  • Regulatory Affairs and Quality

    3 weeks ago

    United Kingdom Syneos Health Full time

    Senior Professional, Quality Management Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the...

  • Regulatory Affairs Manager

    4 weeks ago

    United Kingdom MERJE Full time

    This is an excellent opportunity to join a leading insurance company as a Regulatory Affairs Manager. The successful candidate will be responsible for providing guidance, aid and advice to the company's UK businesses and compliance colleagues on technical compliance matters and regulatory developments. Key Responsibilities: Establishing and...

  • Regulatory Affairs Manager Healthcare

    3 weeks ago

    United Kingdom Immunocore Full time

    Regulatory Submissions, Manager Vacancy Name Regulatory Submissions, Manager Employment Type Permanent IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune...

  • Ad-Hoc Senior Regulatory Affairs Consultant

    4 weeks ago

    United Kingdom Brightwork Ltd Full time

    BaxMed – Ad-Hoc Senior Regulatory Affairs Consultant Led by Stuart Baxter, a seasoned professional with a distinguished career in Regulatory Affairs, BaxMed Regulatory Ltd is an exciting early-stage organisation formed to provide Regulatory and Quality Compliance Services for the global Medical Device / healthcare sector. With a core ethos and commitment...

  • Senior Regulatory Affairs Associate

    2 weeks ago

    United Kingdom Meet Recruitment Limited Full time

    Job Title: Senior Regulatory Affairs Associate Location: Fully remote Company Description: We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team. Position Overview: As a...

  • Regulatory Affairs Executive

    3 days ago

    United Kingdom Callisto Pharma Group Full time

    Regulatory Affairs Executive Due to continued expansion and new Client projects we are currently seeking an additional Regulatory Affairs Executive to join our team in a well-established Consultancy. You would have proven success in your current role and an ambition to continually develop together with commercial awareness, a drive to innovate and be a key...

  • Senior Regulatory Affairs Associate contract job

    2 weeks ago

    United Kingdom Meet Recruitment Limited Full time

    Job Title: Senior Regulatory Affairs Associate Fully remote We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies. Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team. As a Senior Regulatory Affairs Associate, you will play...

  • Regulatory Affairs Specialist

    2 weeks ago

    United Kingdom Meet Full time

    Job Title: Regulatory Affairs Specialist - Medical Device Location: Fully remoteCompany Description:We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies.Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team.Position Overview:As a...