Regulatory Affairs and Quality Manager - Egypt and Sudan

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:

1. Daily follow up and communicate effectively with regulatory authorities to obtain timely product approvals 
2. Negotiating with Regulatory authorities for any issues related to Regulatory
3. Keeping up to date with changes in regulatory legislation and guidelines by attending meetings with MOH
4. Getting importation approval from MOH for any upcoming commercialized or tender shipment in case the issue is related to regulatory
5. Preparing variations files, pricing documents and renewals files to strict deadlines
6. Complete forms and requests originating from government agencies
7. Providing guidance and advice on new project and any new variations
8. Provide central regulatory team with updated registration requirements for new projects/variations
9. Follow up on artwork compliance as per regulation, to avoid delay or rejection of any shipment due to artwork
10. Develop regulatory strategies and implementation plans for the preparation and submission of new products
11. Develop regulatory strategies and implementation plans for the preparation and submission of new products
12. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly
13. Report progress on Global or Group project plans on a consolidated basis
14. Quality 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