Senior Manager Regulatory Affairs

2 days ago


india Rubicon Research Limited Full time

About Rubicon Research

Rubicon Research Limited is a fast-growing pharmaceutical formulations company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets.

Our product portfolio comprises over 250 SKUs across more than 70 product families. We have an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma that markets non-branded prescription products and Validus Pharmaceuticals that markets branded prescription products and promotes them to healthcare practitioners in the US.

We have two US FDA inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with a range of drug development and manufacturing capabilities across dosage forms.

Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA.

For additional information visit www.rubicon.co.in


Position Title: Senior Manager, Regulatory Affairs

Type: Full time

Location: Thane, Maharashtra.



Position Overview:

Manage product registrations in key regulated markets of Canada and Australia including preparing dossiers, submitting applications for product registrations, addressing query responses to obtain product approvals, submitting necessary post approval variations and meeting any annual requirements. Liaise with the cross-functional teams and manufacturing plant to obtain needful documents for product filings. Interacting with the regulatory bodies as required on administrative and technical matters. Manage a team of professionals to deliver the planned filings and necessary approvals.


Key Responsibilities:

  • Managing product registrations in key regulated markets of Canada and Australia including preparing dossiers, submitting applications for product registrations, and addressing query responses to obtain product approvals.
  • Submitting necessary post approval variations and meeting any annual requirements in these markets.
  • Liaise with the cross-functional teams and manufacturing plant to obtain needful documents for product filings.
  • Interact with the regulatory bodies as required on administrative and technical matters.
  • Manage a team of professionals to deliver the planned filings and necessary approvals.


Qualification:

  • Must have 10-15 years of Regulatory experience especially CA and AU markets.
  • Should have experience in dossier preparation, submission, query responses and registration in key regulated countries.
  • Should be an M.Pharm/M.Sc
  • Good communication and planning skills


Additional:

Role is expected to work in all shifts.

Expected to visit Ambernath or Satara site as required.



  • india Medical Learning Hub Full time

    Clinical Affairs ManagerJoin the Future of HealthcareTC4A, a pioneer in democratizing healthcare innovations, is revolutionizing diagnostics with LightAI. We are seeking talented individuals to join our office in Noida and address one of healthcare’s biggest challenges, the overuse of antibiotics that leads to drug-resistant infections and costs billions...


  • India Medical Learning Hub Full time

    Clinical Affairs Manager Join the Future of Healthcare TC4A, a pioneer in democratizing healthcare innovations, is revolutionizing diagnostics with LightAI. We are seeking talented individuals to join our office in Noida and address one of healthcare’s biggest challenges, the overuse of antibiotics that leads to drug-resistant infections and costs...


  • india Rubicon Research Limited Full time

    About Rubicon Research Rubicon Research Limited is a fast-growing pharmaceutical formulations company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. Our product portfolio comprises over 250 SKUs across more than 70 product...


  • india Mirchandanis Career Placements India Pvt. Ltd. Full time

    Job Summary: We are seeking an experienced and dynamic Corporate Relations Manager to lead our government affairs and corporate relations efforts. The ideal candidate will be responsible for developing and maintaining relationships with policymakers, trade associations, and critical stakeholders to support and further our business goals. This role involves...


  • india Biocon Full time

    Role - Formulation Regulatory Affairs Role - US / Canada MarketLevel - Associate Manager / Manager - US Market Required Education/Exp: Experience Req.: 10 - 16 yrs.Qualification: - M.Sc. / M. Pharma.ResponsibilitiesHands on experience on preparation, review and submission of ANDA/ANDS in US Market, including Modules.Experience and knowledge on life cycle...


  • india Biocon Biologics Full time

    At BBL we leverage cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. Intentional curiosity and an innate entrepreneurial scientific spirit fuel our strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other...


  • india Radiant Systems Inc Full time

    SUMMARY OF POSITION: The Regulatory & Technical Data Migration Specialist supports Global Regulatory Affairs through the migration of Regulatory &Technical Data from EtQ L&R to EtQ RIMS, as part of the Regulatory Affairs RIMS implementation project. The successful candidate will possess the ability to evaluate and collaborate to determine the best path to...


  • India Radiant Systems Inc Full time

    SUMMARY OF POSITION:The Regulatory & Technical Data Migration Specialist supports Global Regulatory Affairs through the migration of Regulatory &Technical Data from EtQ L&R to EtQ RIMS, as part of the Regulatory Affairs RIMS implementation project. The successful candidate will possess the ability to evaluate and collaborate to determine the best path to...


  • india Radiant Systems Inc Full time

    SUMMARY OF POSITION:The Regulatory & Technical Data Migration Specialist supports Global Regulatory Affairs through the migration of Regulatory &Technical Data from EtQ L&R to EtQ RIMS, as part of the Regulatory Affairs RIMS implementation project. The successful candidate will possess the ability to evaluate and collaborate to determine the best path to...


  • India ProductLife Group Full time

    **Specific activities and responsibilities**: Australia / South Africa / Brazil and GCC experience **Required education**: Degree in relevant life science discipline **Required experience**: 2-4 years relevant experience for Australia / South Africa / Brazil and GCC experience **Required technical skills**: - Lifecycle maintenance experience - Providing...


  • India Ashoka University Full time

    **Reports to: Vice Chancellor** **Location: Sonipat, NCR** **Experience (in years): Minimum 18 years** **Nature of work: Full Time** **About Ashoka X** **About Ashoka University**: 10 years ago, we embarked on a journey to establish a world-class, multi-disciplinary, liberal arts and sciences university in India. Built on the finest global best...

  • Public Policy

    1 month ago


    india airtel Full time

    Job Description –Public Policy & Regulatory Strategy Team Job Title - Senior Manager Location - Gurugram WHAT WILL YOU BE DOING? Regulatory Managers at Airtel are curious, problem-solvers and self-starters, working at a fast pace to design solutions with our customers and users in mind. At Airtel, the Regulatory team is responsible for development and...

  • Public Policy

    1 month ago


    india airtel Full time

    Job Description –Public Policy & Regulatory Strategy TeamJob Title - Senior ManagerLocation - GurugramWHAT WILL YOU BE DOING?Regulatory Managers at Airtel are curious, problem-solvers and self-starters, working at a fast pace to design solutions with our customers and users in mind. At Airtel, the Regulatory team is responsible for development and...

  • Public Policy

    1 month ago


    india airtel Full time

    Job Description –Public Policy & Regulatory Strategy Team Job Title - Senior Manager Location - Gurugram WHAT WILL YOU BE DOING? Regulatory Managers at Airtel are curious, problem-solvers and self-starters, working at a fast pace to design solutions with our customers and users in mind. At Airtel, the Regulatory team is responsible for development and...


  • India Manager, Biostatistics Full time

    Premier Research is looking for a Manager Biostatistics to join our Biostatistics team in India. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team...


  • india Manager, Biostatistics Full time

    Premier Research is looking for a Manager Biostatistics to join our Biostatistics team in India. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team...


  • India Manager, Biostatistics Full time

    Premier Research is looking for a Manager Biostatistics to join our Biostatistics team in India. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team...


  • India Manager, Biostatistics Full time

    Premier Research is looking for a Manager Biostatistics to join our Biostatistics team in India. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members...


  • india Manager, Biostatistics Full time

    Premier Research is looking for a Manager Biostatistics to join our Biostatistics team in India. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members...

  • Senior Manager

    1 month ago


    india LifeStyles Healthcare Full time

    # LifeStyles is currently looking for new talents #” Job Description: Position: Senior Manager – Quality Assurance Position Reports to: Director – Quality Assurance Downline Reporting: Manager – QA, Associate Manager – QA & QC, Manager – in Process QC, Associate Manager – QA & RA, Executives, and Junior Executives. Location: Plant –...