Asuncion Redondo

• Strategic Planning of all Regulatory Activities for Medicines, Food Supplements and Medical Devices in Gulf Countries and Levant.
• Submission of new products. (eCTD)and life cycle management.

*KSA, UAE and Kuwait submissions validated with no questions.

• Change of medicines dispensing mode. (Approved from Prescription to Pharmacy only)
• High expertise in labelling to comply with all Middle East country's harmonized packaging.

*42 submissions in 3 months to upgrade SPC and Leaflets approved.

• Identification of potential COMPLIANCE gaps through a high level of endorsement with national, and international regulations and internal requirements.
• In charge of Audit and Conformity Assessment (Quality Management & Safety)

*Single Point of Contact in 8 internal audits. All closed on time.

• Lead the preparation of internal Standard Operation Procedures in Regulatory and revision of internal advertising materials.
• Deployment of Track and Trace platforms in the Middle East (BrandSync, Tatmeen, NHRA-MVC etc): KSA, Bahrein, UAE and initial work for Qatar.
• Participation in multitask teams providing regulatory perspective for optimised project outcomes. (Agile Way of Working Method)

• Managing and executing regulatory activities across EMEA (Europe, Middle East and Africa) within Over-The-Counter brand categories for National and EU-registered products.
• Leading the dossier preparation and submission strategy to register a Medicinal Shampoo through a Mutual Recognition Procedure (Country of Reference: Hungary).
• Coordinating multiple projects (i.e; Labelling, Quality, Updates on European Regulations) and representing the function as a prime internal Regulatory contact in the following areas of responsibility:

*Topical Healthcare (Anti Fungus)

*Hair Growth (Minoxidil) and Eye Care franchise.

*Medical Devices Class II.

• Delivered Emerging Markets Growth Plans in the Middle East and South Africa. This project included:

*Construction of 7 bibliographic dossiers from scratch. (Pain, DH and C&C)

*Preparation of labelling and development of claims.

*33 submissions accepted across Gulf Countries, Levant and Egypt.

*Follow up end-to-end till getting approval.

Note: McNeil Consumer Healthcare from September 2007 due to a spin-off of Pfizer Consumer Healthcare business.

• Leading the regulatory activities, (submissions, life cycle management) of the following therapeutic areas:

*Digestive Health (Loperamide).

*Pain-Miscellaneous (Different brands).

*Oral Care: Mouthwashes

• Revision of marketing advertising materials and submission to Health Authorities for Approval.
• Liaised with the Spanish Agency of Medicines and Medical Devices to discuss indications, packaging design approval and dispensing mode.
• Coordination of labelling implementation with the Supply Chain department to confirm correct version in the market.

• Responsible for all regulatory activities related to the Central Nervous System pharmaceutical area (New product introduction and Life Cycle Management)
• Submission of a new indication approved by Spanish Health Authorities.

* Submitted and approved with no questions.

• Dossier preparation for submission of new products in this category by European Procedures (DCP, MRP) and support to other pharmaceutical areas to revise the accuracy of the dossier and labelling.
• Preparation of the registration dossier of an anti-fungal as Generic.
• Coordination with regulatory and software technical groups seated in Global Headquarters in the USA to build and deploy the first regulatory database for the company worldwide.

*This database is still in use. (Upgraded versions)

• Planning and managing tasks related to Regulatory Affairs, Pharmacovigilance and Quality Person- relevant actions to release the product into the Spanish Market.
• Coordinate with marketing OTC regulatory strategies
• Liaison with Spanish Agency personnel, as appropriate.
• Coordinating the implementation of Regional Procedures into local SOPs
• Leading the maintenance of warehouse authorizations for Medicines, Cosmetics and Medical Devices.

• Support patients on optimal dosage, methods of administration and drug compatibility prior to dispensing medications.
• Provide patients with instructions about taking, handling and storing medications.
• Give advice to customers on the effective and safe usage of non-prescription products.
• Implementing a project named “Pharmaceutical attention to patients” to improve patient relationships and healthcare support.