Regulatory Affairs Specialist

Isotopia, a manufacturer of medicinal products for the local and global markets, is looking for a Regulatory Affairs Specialist to support in RA activities related to registration, submission and maintenance of Marketing Authorizations (MA) and Drug Master Files (DMF).

Responsibilities

• Routine support and collaboration with the Head of Global Regulatory Affairs in administrative activities related to submissions and technical preparation of dossiers.
• Maintain compliance with post-marketing commitments and maintenance of licenses/authorizations for existing products, including review/approval of internal specifications, evaluation of changes in product or processes to determine regulatory impact
• Support in the preparation and management of technical documentation for regulatory submissions in a timely manner.
• Review documentation intended for regulatory submissions to ensure relevant regulatory requirements are met.
• Responsibility for approval and modifications of packaging materials.
• Collaborate and share knowledge with cross-functional teams such as R&D, QA, QC and supply chain.
• Draft responses to questions raised by regulatory authorities.
• Work alongside the appointed pharmacist for local market submissions.
• Control own daily activities in alignment with the division’s goals and priorities.
• Interface with Isotopia’s contract manufacturers, partners and suppliers to ensure efficient collaboration and compliant resolution of issues.

Qualifications

• Relevant academic degree in life sciences.
• At least three years of regulatory affairs experience, preferably in a global company.
• Experience in regulatory CMC is an advantage
• Proficient in written and spoken English

Reports to:

Head of Global Regulatory Affairs

Location:

Petach Tikva, Israel (on-site)