Regulatory Affairs Executive

3 days ago

مصر, Egypt Jamjoom Pharma Full time

As a Regulatory Affairs Executive, you will be responsible for the day-to-day monitoring of the company’s regulatory activities to ensure compliance with all regulations. You will be a key member of our regulatory affairs team, which is responsible for the company’s regulatory processes and reporting of the regulatory activities.

**Responsibilities**
- Ensuring compliance with all regulatory requirements
- Preparation and submission of all regulatory reports
- Providing accurate reviews of data and reports
- Ensuring accurate and timely submissions to regulatory agencies
- Advising others on regulatory and compliance matters
- Coordinate efforts associated with the preparation of regulatory documents or submissions.
- Pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
- Coordinate, prepare, or review regulatory submissions for projects.
- Prepare or maintain technical files as necessary to obtain and sustain product approval.
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
- Determine the types of regulatory submissions or internal documentation that are required in changes.
- Identify relevant guidance documents, international standards, or consensus standards.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Compile and maintain regulatory documentation databases or systems.
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.

**Qualifications**
- Bachelor’s degree in a scientific field such as Pharmacy
- Two years of experience in a similar role
- Excellent verbal and written communication skills
- Strong interpersonal skills
- Excellent customer service skills
- Strong problem-solving skills
- Excellent organizational skills
- Highly developed attention to detail
- Strong project management skills
- Ability to work well in a team environment

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