Regulatory Affairs Specialist

4 weeks ago

Thane, 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: Sr. Executive, Regulatory Affairs

Type: Full time

Location: Thane, Maharashtra.

Reporting To: Manager


Position Overview:

The Regulatory Affairs Sr. Executive will play a critical role in ensuring compliance with regulatory requirements for pharmaceutical products throughout their lifecycle. Involving in ANDA, NDA and Post Approval Preparation, Compilation and Submission, Review of Labeling, Annual Report and PADER Submission.


Key Responsibilities:

  • Review labelling and SPL (Summary of Product Characteristics) for submissions.
  • Prepare, review, and submit pre- and post-approval submissions for pharmaceutical products in the US, EU, and ROW markets.
  • Compile, review, and publish eCTD dossiers for USFDA-ANDA/EU-MAA applications, as well as other regulatory submissions.
  • Work with stakeholders to gather the required data and information for Submission.
  • Review specifications, batch manufacturing, process validation, method validation, and analytical documents for submissions.
  • Manage the process of receiving and responding to deficiencies from regulatory authorities.


Qualification:

B.Pharm / M.Pharm (Must)

More than 6 years of experience of USFDA / ANDA / Europe regulatory.

Handled ANDA/NDA submissions.


Additional:

Role is expected to work in all shifts.

Expected to visit Ambernath or Satara site as required.

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