Regulatory Affairs Specialist

2 days ago

th of October City, Egypt Adamco Pharm Full time

**Adamco Pharm**is a fast-growing international pharmaceutical holding Company based in Cairo - Egypt, that is responsible for managing international business through searching for new market opportunities where it can expand the volume of the business.

**Adamco Pharm** is a commercial pharmaceutical agency with a medical portfolio that surpasses 100 products and more than 150 SKUs.

**Adamco Pharm** holding owns a group of subsidiaries, as EGY Nile Pharm in Burkina, Niger, and Mali, and Egypt Niger.

**VACANCY**:

- Designation: Regulatory Affairs Specialist
- Location: Adamco Pharm, 6 October, Giza
- Reporting: Regulatory Affairs Manager

**Job Purpose**:
**A. Essential Duties and Responsibilities**:

- Ensure regulatory compliance of products, labels, advertising and promotions as well as adherence to company policies and guidelines.
- Stay abreast of regulatory developments and identify opportunities and implications to the business.
- Collaborate with business partners to ensure that product labeling and advertising are competitive and contribute to optimal marketing of products.
- Respond to written questions form regulatory agencies as necessary.
- Submit and follow-up on approval for product changes with regulatory authorities.
- Maintain regulatory files for International submissions/documents with foundational understanding of the CTD format and requirements.
- Interpret existing or new international regulatory guidelines as they relate to company products, procedures, and policies.
- Prepare/revise regulatory procedures as required.
- Provide input to project teams to assure regulatory authority requirements are incorporated as part of the product development process.
- Assist with product registrations.
- Retrieve guidelines and other regulatory information from the internet and other appropriate sources.
- Attend appropriate regulatory meetings and maintain update on regulatory changes.
- Document and archive these discussions and communicate discussions with internal stakeholders as necessary.

**B. Job Requirements**:
1. Level of Education:

- B.Sc. in Pharmacy is essential

2. Experience:

- Previous experience of Pharmaceutical Regulatory role is desired

3. Language:

- Excellent verbal, written and interpersonal communication skills. English fluency essential

4.IT Literacy:

- Professional computer and MS-Office skills

**C. Competencies and Behaviors**:

- Experience in collaborating with cross functional business partners to ensure timely and quality execution of multiple projects
- Demonstrated ability to complete projects/tasks with high level of autonomy (highly self-motivated).
- Good understanding of marketing and consumers benefits.
- Time Management (Organized) and detail oriented
- Experience of working in a multicultural teams and environment
- Team Player; ability to support and lead to achieve common goals
- Strong Communication and Presentation skills
- Problem solving: Proactive and resourceful in solving problems, offering innovative and practical solutions in dynamic environment

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