Alaa Shaheen 🇵🇸 Email and Phone Number

- Working with governmental regulatory bodies to establish strategic regulatory plans for KSA and UAE - Performing the CMC, non- clinical checks for the in-licensed biotech products - Implementing regulatory standards of excellence through developing effective work approaches, procedures and processes to ensure quality and enhance the company’s image - Representing the company in biotech related communication with global partners and regulatory agencies - Consolidating global information relevant to biotech products and monitoring global submissions and approvals status- working with internal team to accomplish regulatory objectives and ensure full compliance before submission in KSA and UAE markets

In-licensing Dossiers (biologics and biosimilars) :evaluation of dossier content (CMC and clinical part ) before signing the commercial agreement Meeting with authorities to display presentations about MSpharma products Compile answers with respect to questions received by regulatory affairs at the affiliates from registration authorities by contacting dossiers suppliers Responsible for the alignment of all affiliates with corporate overall strategy and consolidating all related needed data Keeping an eye on all the changes in the market dynamics in the country of origin and all countries of presence to ensure continues development and improvement in the corporate Following up with all departments and teams the main projects that will add to the overall success of Ms pharma as an innovative healthcare provider