Rubicon Research Hiring Sr. Executive – Regulatory Affairs – RoW

Rubicon Research Hiring Sr. Executive – Regulatory Affairs – RoW

19 July, 2022

Rubicon Research Hiring Sr. Executive – Regulatory Affairs – RoW

Key Responsibilities:

  • Play a pivotal role in the preparation, review, and submission of product registration dossiers (CTD/ACTD/eCTD) for Global Dossier Development and Submission
  • Ensure accuracy, completeness and quality of the dossiers and compliance of the dossiers with the regulatory guidelines.
  • Co-ordinate with internal and external stakeholders to compile documents, prepare dossiers and ensure timely registrations as per the business plan.
  • Interact with Regulatory Agencies/Agents/Partners to respond in a timely manner any queries or deficiencies from the Regulatory Agencies.
  • Manage post-registration renewals, changes, or variations for the product.
  • Co-ordinate to ensure all product artworks are available and submitted for registration or any post-registration variations as required.
  • Be up to date with the current regulations and guidelines.
  • Work with an overall objective to receive approvals within the shortest time frames possible.

Candidate Profile:

  • Master’s Degree in Pharmacy or related field – Preferred.
  • 8-10 years of experience in Regulatory Affairs for ROW markets
  • Must possess knowledge of regulatory guidelines, CTD/ACTD/eCTD, ICH, and understanding of various dosage forms
  • Must have a working experience of correspondence with ANVISA, ANMAT, COFEPRIS, TGA, SAHPRA, SDFA etc.

Key Attributes:

  • High Energy and good communication skills (written and verbal)
  • Proactive and results oriented with a positive attitude
  • Good interpersonal skills with strong ability to collaborate effectively with individuals at all levels of organization and with the regulators
  • Detailed oriented with work of highest quality
  • Proven ability to work with tight deadlines to achieve corporate goals

Apply HERE

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