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