Regulatory Affairs Sr. Executive

2 months ago

Jeddah, Saudi Arabia Jamjoom pharma Full time

Jamjoom Pharma has in a very short span of time emerged, as one of the leading pharmaceutical companies in the Afrasia region. The geographical focus of the company is on countries in the Middle East, Africa, and CIS regions. Strategic focus on selected therapeutic categories has contributed to the rapid growth, market acceptance, and overall success of the company.

**Role Summary**:
Responsible to ensure Jamjoom Pharma product submissions are complying with the guidelines and meeting the timelines as per annual plan through healthy relationship and strong follow up with inter/intra departments and regulatory associates.

**Responsibilities**:

- Compile and submit, in a timely manner, regulatory documents according to regulatory requirements and regular follow up on the submitted files.
- Ensure timely submissions as well tightly manage deficiency responses.
- Work with market regulatory manager to develop a detailed understanding of regulatory guidelines and technical requirements in assigned countries.
- Work with the manager to develop and execute regulatory plans for complex projects including transfer of the newly acquired products and maintenance of licenses/authorizations for existing marketing authorizations.
- Work on Renewals (products and sites) submit the request as per the date mentioned in the renewal tracker.
- Provides solutions to a variety of problems of moderate scope of complexity.
- Interacts with internal and/or external clients.
- Labelling: annotation and review of the artworks in compliance with local labelling guidelines. Artwork release when any approval is received and ensures all relevant stakeholders is informed.
- Ensure a proper archiving for any submitted dossier (soft copy)
- Work on assigned projects to assist other affiliate where needed based on the business priority
- Identify changes and modifications in the healthcare regulatory environment; and communicate those changes to appropriate individuals and departments for implementing into the organization’s processes.
- Execution of Section short to mid-term strategic plan to ensure alignment with the Section’s strategic priorities, and the corporate goals.
- Contribute to the development of annual business plans for the assigned areas of responsibility to support the achievement of financial and strategic objectives.
- Ensures function is performing its work in accordance with established standards and remain abreast of emerging trends and best practices in the industry.
- Participate in business and technology initiatives and projects ensuring that its perspective is effectively communicated.
- Providing accurate pharmaceutical information about the company's products traded in the Kingdom to beneficiaries and workers in the fields of health.
- Ensure the accuracy of the information used in the marketing of the company's registered products and their conformity with the written information approved by the Authority.
- Ensure that the company represented by the Office adheres to the Saudi Code of Ethics in the Practice of Pharmaceutical Marketing.
- Implementation of regulations and instructions issued by the Authority.
- Support scientific activities in the fields related to the company's products traded in the Kingdom, participate in the activities of scientific associations and contribute to continuing education programs.
- Follow-up of the company's products after registration and marketing and informing the authority of any observations regarding the quality and effectiveness of the product or the emergence of side effects or pharmaceutical errors after marketing during the specified period.
- Continue to update the leaflet and packaging of the registered product and make sure that its information matches what is approved by the Authority.

**Qualifications**:

- Bachelor of Pharma D, or related field.
- 1 to 3 years of experience in the relevant field.
- Excellent oral and written communication and presentation skills.
- Excellent interpersonal and collaboration skills, including diplomacy to negotiate conflicting priorities.
- Proficient computer skills including MS Office, RIS, eCTD, SAP.

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