Senior Manager Regulatory Affairs
2 weeks ago
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.
-
Regulatory Affairs Manager
18 hours ago
India Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full timeAbout Medisal Pharma As a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products to enhance global health by developing and delivering high-quality, affordable medicines. With a strong emphasis on innovation, research, and excellence, we aim to make a...
-
Regulatory Affairs Manager
22 hours ago
India Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full timeAbout Medisal PharmaAs a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products to enhance global health by developing and delivering high-quality, affordable medicines. With a strong emphasis on innovation, research, and excellence, we aim to make a significant...
-
Regulatory Affairs Manager
10 hours ago
India Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full timeAbout Medisal Pharma As a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products to enhance global health by developing and delivering high-quality, affordable medicines. With a strong emphasis on innovation, research, and excellence, we aim to make a significant...
-
Regulatory Affairs Specialist
1 week ago
India Apsida Life Science Full timeApsida Life Science are looking for a Regulatory Affairs Specialist for a long term project.Immediate start!!!You will need to Provide regulatory advice, verify strategic approaches and timelines, and align zone strategies with Affiliate Regulatory Affairs teams.Apply knowledge of regulatory requirements in Vietnam, Philippines, Thailand, Malaysia, Singapore...
-
Director Quality Regulatory Affairs
4 days ago
India Qure.ai Full timeAbout Qure.AI: Qure.AI is the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. We develop cutting-edge solutions that significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted...
-
Director Quality Regulatory Affairs
4 days ago
India Qure.ai Full timeAbout Qure.AI: Qure.AI is the world's fastest-growing medical AI company, boasting an impressive 18 FDA and 62 CE marking clearances to date. We develop cutting-edge solutions that significantly enhance patient outcomes across various care domains, including lung cancer, tuberculosis, and stroke. Our innovative technologies have positively impacted...
-
India Apsida Life Science Full timeApsida Life Science is seeking a Regulatory Affairs Specialist for a long-term project in the Asia-Pacific region. The ideal candidate will have expertise in regulatory requirements for Vietnam, Philippines, Thailand, Malaysia, Singapore, and other ROW countries.The role involves providing strategic guidance on regulatory compliance, collaborating with...
-
india Apsida Life Science Full timeApsida Life Science are looking for a Regulatory Affairs Specialist for a long term project. Immediate start!!! You will need to Provide regulatory advice, verify strategic approaches and timelines, and align zone strategies with Affiliate Regulatory Affairs teams. Apply knowledge of regulatory requirements in Vietnam, Philippines, Thailand, Malaysia,...
-
india Apsida Life Science Full timeApsida Life Science are looking for a Regulatory Affairs Specialist for a long term project. Immediate start!!! You will need to Provide regulatory advice, verify strategic approaches and timelines, and align zone strategies with Affiliate Regulatory Affairs teams. Apply knowledge of regulatory requirements in Vietnam, Philippines, Thailand, Malaysia,...
-
india Apsida Life Science Full timeApsida Life Science are looking for a Regulatory Affairs Specialist for a long term project.Immediate start!!!You will need to Provide regulatory advice, verify strategic approaches and timelines, and align zone strategies with Affiliate Regulatory Affairs teams.Apply knowledge of regulatory requirements in Vietnam, Philippines, Thailand, Malaysia, Singapore...
-
Manager Clinical Affairs
3 weeks ago
india Medical Learning Hub Full timeClinical 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...
-
Manager Clinical Affairs
3 weeks ago
India Medical Learning Hub Full timeClinical 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...
-
Panacea Biotec | Senior Manager
4 days ago
india Panacea Biotec Full timeSenior Manager - Regulatory Affairs (EU & US Markets)Job Summary:Execution of successful dossier filing without any major query / deficiency.Respond to the queries raised by the regulatory body within stipulated timelines and minimum queries.Proper maintenance of records & their archival.Key Responsibilities:Compilation of the registration dossier in...
-
Medisal Pharma
24 hours ago
india Medisal Pharma - Medisal for Pharmaceuticals Industry LLC Full timeAbout Medisal PharmaAs a proud United Arab Emirates company based in Abu Dhabi, Medisal Pharma is dedicated to excellence in manufacturing high-quality pharmaceutical products to enhance global health by developing and delivering high-quality, affordable medicines. With a strong emphasis on innovation, research, and excellence, we aim to make a significant...
-
india Rubicon Research Limited Full timeAbout 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...
-
Regulatory Analyst
1 week ago
india Evoke HR Solutions Pvt. Ltd. Full timeResponsibilities -Perform electronic submissions on ectd express for EU,USEH/US Submission via CESP gatewayISI Toolbox, CARA ETD eCTD express, CTD Regulatory Affaires Regulatory Publishing and SubmissionQualifications - B.pharma, M.Pharma, M.Sc
-
Regulatory Analyst
1 week ago
india Evoke HR Solutions Pvt. Ltd. Full timeResponsibilities-Perform electronic submissions on ectd express for EU,USEH/US Submission via CESP gatewayISI Toolbox, CARA ETD eCTD express, CTD Regulatory Affaires Regulatory Publishing and SubmissionQualifications- B.pharma, M.Pharma, M.Sc
-
Regulatory Affairs Officer
5 months ago
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...
-
Regulatory Affairs Specialist
4 days ago
India Dozee Full timeOverview : Include dossier preparation, on-time tracking of applications and network with regulatory bodies and bring in compliance. Play an active role in a change environment Supports the ongoing implementation and sustainment of Quality and Regulatory compliance as per local and international rules and regulations. Responsibilities : Plan,...
-
Public Policy
2 months ago
india airtel Full timeJob 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...
