AM / DM - REGULATORY AFFAIRS Jubilant Biosys Limited Accelerating Drug Discovery

4 weeks ago

United Kingdom PharmaGroww Full time

JOB DESCRIPTION

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.

Jubilant Generics (JGL) is a wholly – owned subsidiary of Jubilant Pharma. 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. API portfolio focusses on Lifestyle driven Therapeutic Areas (CVS, CNS) and targets complex and newly approved molecules. 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. This business focusses on B2B model for EU, Canada and emerging markets.

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.

Kindly refer for more information about organization.

JOB DESCRIPTION :

Accountabilities Scope of work

Europe/Australia/ Canada

  • Drug Dossier Authoring, Reviewing & Submission drug product dossier application (EU/UK/AU/CA)
  • Product life cycle management (LCM) activities
  • Assessment ofpost approval changes
  • eCTD publishing
  • Thorough knowledge of CMC and Module 1 requirements
Preparation & Submission

  • Authoring and review & submission of new dossier application, variation, renewal and RFI for EU (DCP/MRP/NP), UK, Australia & Canada Health Authority
  • 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
  • Review and finalization of artwork/label as per current QRD guideline
  • Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends
  • eCTD publishing
Coordination

  • 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
  • To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ADL against DMF/Dossier requirements
Reporting & Maintenance

  • Maintain regulatory files/database
#J-18808-Ljbffr

  • Drug Regulatory Affairs Professional

    1 month ago

    United Kingdom Igmpiindia Full time

    Conferment of the prestigious "BUREAU OF INDIAN STANDARDS (BIS) AWARD OF HONOUR 2023" to IGMPI Certified Drug Regulatory Affairs Professional IGMPI has brought an opportunity to become a Certified Drug Regulatory Affairs Professional for those who understand the basic stages of the industrial production life cycle and their regulatory requirements. The...

  • Senior Regulatory Affairs Associate

    1 month ago

    United Kingdom invoX Pharma Limited Full time

    Senior Regulatory Affairs Associate - Drug/Device (Contractor) Department: Regulatory Employment Type: Contract / Temp Location: invoX Remote (UK) Reporting To: Marie Morris Description Description of Services To help continue our growth and success, we are looking a Contract Senior Regulatory Affairs Associate to support the delivery of...

  • Regulatory Affairs Specialist

    2 days ago

    United Kingdom Meet Recruitment Limited Full time

    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 all relevant regulations and standards in various...

  • Associate Regulatory Affairs Director

    6 days ago

    United Kingdom Gilead Sciences, Inc. Full time

    Global Regulatory Affairs, Associate Director (Oncology) Global Regulatory Affairs, Associate Director (Oncology) United Kingdom - Cambridge, United Kingdom - Uxbridge Regulatory Regular Job Description For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that...

  • Associate Regulatory Affairs Director

    2 weeks ago

    United Kingdom Gilead Sciences, Inc. Full time

    Global Regulatory Affairs, Associate Director (Oncology) Global Regulatory Affairs, Associate Director (Oncology) United Kingdom - Cambridge, United Kingdom - Uxbridge Regulatory Regular Job Description For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that...

  • Regulatory Affairs Executive

    2 weeks 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 Manager, Regulatory Affairs

    5 days ago

    United Kingdom ICON Plc Full time

    United Kingdom- Remote or Hybrid (Reading, Swansea) At ICON, it’s our people that set us apart. As a global provider of drug development solutions, our work is serious business. But that doesn’t mean you can’t have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the...

  • Regulatory Affairs Manager Healthcare

    1 month 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...

  • Regulatory Affairs Specialist

    6 days ago

    United Kingdom Meet Recruitment Limited Full time

    3 weeks ago Be among the first 25 applicants Senior Consultant Specialising In Regulatory Affairs I am working with a growing pharmaceutical company who provide over-the-counter (OTC) pharmaceutical products dedicated to enhancing the health and well-being of customers. They're currently in the next phase of growth for the company as they're...

  • Student Placement: Regulatory Affairs

    1 month ago

    United Kingdom Igmpiindia Full time

    Conferment of the prestigious "BUREAU OF INDIAN STANDARDS (BIS) AWARD OF HONOUR 2023" to IGMPI Certified Drug Regulatory Affairs Professional IGMPI has brought an opportunity to become a Certified Drug Regulatory Affairs Professional for those who understand the basic stages of the industrial production life cycle and their regulatory requirements. The...

  • Senior Regulatory Affairs Specialist

    1 week ago

    United Kingdom Mosaic Regulatory Solutions Full time

    This global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...

  • Regulatory Specialist

    6 days 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

    3 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

    3 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

    3 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

    3 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 Manager

    1 month ago

    United Kingdom Precisionscientia Full time

    Precision for Medicine (CRO) are recruiting a Regulatory Manager to join our team, candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland. The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan...

  • Regulatory Affairs Specialist

    1 week ago

    United Kingdom Groupe ProductLife Full time

    In the context of our growing activities, we are looking for a Regulatory Affairs Specialist to join our teams in Spain. You will integrate a team of Regulatory Affairs professionals dedicated to Southern Europe and will have the mission to develop PLG’s local Spain Regulatory Affairs presence, taking responsibility for new regulatory activities related...

  • Regulatory Affairs Specialist

    1 week ago

    United Kingdom Groupe ProductLife Full time

    In the context of our growing activities, we are looking for a Regulatory Affairs Specialist to join our teams in the United Kingdom. You will integrate a team of dedicated Regulatory Affairs professionals and will have the mission to develop PLG’s local UK Regulatory Affairs presence, taking responsibility for new regulatory activities related to the UK...

  • Regulatory Affairs Specialist

    1 month 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,...