Egypt Job Openings
Aspen Pharma Group
Regulatory Affairs and Quality Manager - Egypt and Sudan - Egypt
FULL TIME
November 21, 2024
ROLE PURPOSE:
RESPONSIBILITIES:
- 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:
- Daily follow up and communicate effectively with regulatory authorities to obtain timely product approvals
- Negotiating with Regulatory authorities for any issues related to Regulatory
- Keeping up to date with changes in regulatory legislation and guidelines by attending meetings with MOH
- Getting importation approval from MOH for any upcoming commercialized or tender shipment in case the issue is related to regulatory
- Preparing variations files, pricing documents and renewals files to strict deadlines
- Complete forms and requests originating from government agencies
- Providing guidance and advice on new project and any new variations
- Provide central regulatory team with updated registration requirements for new projects/variations
- Follow up on artwork compliance as per regulation, to avoid delay or rejection of any shipment due to artwork
- Develop regulatory strategies and implementation plans for the preparation and submission of new products
- Develop regulatory strategies and implementation plans for the preparation and submission of new products
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly
- Report progress on Global or Group project plans on a consolidated basis
- 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.
- 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:
Years of Experience required (Pharmaceutical industry/consumer health):
Technical skills:
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:
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
We regret to inform you that this job opportunity is no longer available as it has expired
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