ROLE PURPOSE:

• Oversight of the Full Product Life Cycle in the assigned territory and maintaining the license of products.
• Keep the technical dossier updated and comply with the latest technical dossier in country of origin.
• Ensure achieving project & company plans.
• Establish ongoing liaisons with government officials and act as a reference point for updated regulatory intelligence on any changes and upcoming projects related to the assigned territory.

RESPONSIBILITIES:

• Escalate any (time) critical quality issues to EME Quality team for initiating necessary actions.
• Keep up to date with any changes in the legislation and work seamlessly with EME quality personnel as it relates to Quality requirements for Egypt.
• Support compliance with GDP/GMP and other requirements for Egypt and liaising with EME quality team.
• Liaise with EME quality team to ensure efficient handling of returns, distribution complaints, product’s quality complaint, temperature excursion, recall support in line with Technical Agreements.
• Support in returned, recalled, or falsified products investigations, in conjunction with APTL / MA Holder.

15. Local tech transfer projects:

• Oversee all aspects of local technical transfer activities for Egypt
• Oversee local technical transfers in accordance with standard ways of working.
• Develop effective relationships throughout project with local CMO and project team to facilitate communication on the ground.
• Share knowledge, support improvements, and optimize the technical project outcomes.

POSITION REQUIREMENTS:

Level of Education required:

• Bachelor’s degree in pharmaceutical science
• Cert/Diploma - Pharmacist

Years of Experience required (Pharmaceutical industry/consumer health):

• 5+ years of solid Regulatory Affairs and quality experience in a reputable organization/s
• Excellent in-depth knowledge of key business functions such as Sales, business development, marketing, Medical, etc.
• In-depth understanding of the pharmaceutical industry within the country

Technical skills:

• Excellent verbal and written communication skills - Good to advanced
• Negotiation Skills with health authorities and functional areas within the company - Good
• MS Office / computer literate - Good
• Multitasks managing - Interaction with different stakeholders (internally or externally) - Interpersonal skills - Presentation skills - Good
• Proactivity and high initiative to take decisions - Advanced
• Strategic thinker, innovative, able to drive multiple simultaneous initiatives, able to work under pressure - Advanced
• Must be able to work in a fast-paced environment with demonstrated ability to deal with competing tasks and demands - Advanced
• Excellent leadership, managerial, interpersonal and relationship building skills - Good
• Precision, Accuracy, High attention to details. - Flexibility, Team worker Goal-oriented, focused, energetic, and enthusiastic - Advanced

ASPEN COMPETENCIES:

BUSINESS
Foster Consumer & Customer Commitment
Makes Good Decision

PEOPLE
Communicate Effectively
Dealing with ambiguity/Embrace change

SELF
Continuously Grow & Develop
Contribute Special Expertise

KEY ATTRIBUTES:

• Market Knowledge
• Consumer relevancy
• Problem-solving
• Information seeking
• Flexibility and tolerance for ambiguity
• Capacity for and resistance to stress
• Active listening
• Informal communication skills
• Technical /Professional skills
• Industry knowledge
• Curiosity/learning agility