Yousif Elhaty

• Build and develop networks and strong working relationships with internal & external bodies, partners & other internal & externals stakeholders
• Manage activities at a department on both short- and long-term department and company objectives.
• Regulatory Intelligence- Understands the regulatory landscape and Monitors the regulatory environment and provides assessments of the impact of new and changing regulations on the company’s areas of interest
• Manages compliance within the department by ensuring global, regional, and local processes, policies, SOPs and working instructions are in place and adhered to.
• Manage processes to develops, translates, reviews (where relevant) and approves artwork, where relevant, and promotional materials to ensure regulatory compliance for submissions.
• Monitors progress of applications against set timelines, acting where necessary, to minimize delays and anticipate difficulties/challenges.
• Interacts with regulatory agency personnel to expedite approval of pending applications and to resolve regulatory matters.
• Provide coaching, training, and support, as required.
• To be a proactive and credible business partner to Regulatory Affairs and in-market and/or Regional Business colleagues.

-Work cross-functionally to develop and implement integrated regulatory project timelines and identify

resources needed to achieve timely and quality regulatory filings and approvals

- Direct and lead the regulatory affairs function from the stage of product development to life cycle management of products across all therapeutic areas.

- Collaborate with cross functional leaders to identify strategic and operational risks to regulatory timelines and deliverables to create appropriate mitigation and contingency plans

- Develop reporting tools to ensure prompt and concise communication of the status of key submission activities including timeline andresource reports for functional and sr. management review

- Support Business Development activities with regulatory timeline scenarios

- Manage and mentor staff

- Proven leadership skills to impact and influence decision-making within a dynamic team environment

- Demonstrated ability to successfully plan, adjust, manage, and optimize all resources (budgets, staff,

technology, etc.) for advancement of all goals and objectives

- Anticipate regulatory emerging issues and develop solutions to them.

- Utilize technical regulatory skills to propose strategies on complex issues.

- Ensure regulatory support for regional in-licensing and product development opportunities

Planning , preparing , submission and follow-up all the RA activities ( Products & manufacturing sites ) in the GCC region For local Marketing authorization product submission ( from local manufacturer product via our registered Scientific office ) & imported product from different sites of Glenmark Pharmaceuticals in India – Argentina

Registration of the cosmetic products in Dubai Municipality – (Glenmark Pharmaceuticals – Brazil & India )

My role starting from the designing of the packaging material (bilingual - English /Arabic) and leaflet to be complied with the requirements of the health authorities in GCC countries.

- managing and planning for the new registration submission for different kind product from different site in India and Latin America ( direct registration & Central registration )

3- Set the plan for all kind of variations required approval in the region and the renewals process for the entire registered product.

4- Pharmacovigilanceofficer -UAE

Products : dermatology – Cardiovascular – antibiotic & antiviral – analgesic –oncology – MDI

Medicated cosmetic – General sale products

New project for the first NCE from Glenmark Pharmaceutical- India .

1- Development the product labelling and insert leaflet which complying with the regulatory regulation in the region

2- On time development and submission of documents for registration of plant/products and prepare a time line for achieving approval by each market by products

3- Co-ordinate with all relevant department and ensure availability of required data/documents to ensure on time registration/pricing approval

4- Ensure compliance to relevant regulatory guidelines by all departments for all regulatory issues to be complied in each market

5- Regular follow up and visits to regulatory agencies to meet time lines for registration /solve issues if any.

- Coordinate with several international and selected European pharmaceutical companies such as GSK , Boheringer Ingeheim , Dumex , and other local GCC manufacturer like Jazeera

- Preparation and submission of the registration documents following the conformity of the regulatory in UAE

- Answering all requirements required from MOH-UAE and furnishing with the requested pharmaceutical technical and clinical dossiers.

- Acknowledgement of all changes in regulatory and do the necessary amendments.

- Updating the registration list and status for all products and inform all departments for any changes.