Emanuel Almeida

Emanuel Almeida

Affiliations

  • ORDER OF PHARMACISTS – Portuguese Pharmacists Society (since 1982)
  • APREFAR - Portuguese Association of Regulatory Affairs Professionals (since 1993)

Summary

I am a Pharmacist who has been involved in scientific management positions within the Pharmaceutical Industry, namely in the Regulatory Affairs domain, where I have gained considerable experience and expertise in handling complex projects and working in multidisciplinary teams and international environments.

I have significant experience in EU Regulatory Procedures for human medicinal products, together with good knowledge of the dynamics and operational issues involved in drug development. I am currently pursuing new opportunities to develop further my competencies in managing scientific and development projects, working in a multidisciplinary teamwork perspective.

Work History

Work History
Mar 2009 - Jan 2010

Regulatory Affairs Manager

AstraZeneca

Responsible for the regulatory management of projects for specific therapeutic areas, including:

• Management of registration activities (National and EU) for the Oncology and Cardiovascular products

• Preparation of local submissions and updating of the regulatory databases and electronic library system

• Product information and promotional materials review in compliance with the company’s Pharma Code.

• Participation in several multidisciplinary Brand Teams giving strategic regulatory insight

• Regulatory Liaison on a joint-venture project for the Diabetes area (BMS-AZ Alliance).

Jan 2005 - Jan 2008

Regulatory Affairs Coordinator

sanofi-aventis

 Responsible for the Regulatory Projects of Winthrop Business Unit, including:

• Launching of the new Winthrop brand in the whole generics portfolio

• Management of generic product registration activities, for the local projects and for the European procedures (MRP/DCP)

• Management of pricing and reimbursement application procedures

• Auditing of registration dossiers from suppliers and follow-up of in-licensing procedures

• Cooperation with local and Corporate BD for the development of the generics portfolio

• Support to QA for product compliance and supply chain optimisation.

Apr 2000 - Dec 2004

Regulatory Affairs Manager

Aventis Pharma

 Responsible for the regulatory management of some specific business areas, including:

• Local and EU registration procedures of products for:

  Oncology, Anti-infective, Bone/Rheumatology, Thrombosis, Gastro

• Supervision of product scientific information for health professionals

• Support to Marketing for regulatory compliance of promotional items and product packaging

• Management of regulatory procedures database and respective reporting tools.

• Regulatory coordination of Clinical Trials Applications under the new EU guidelines.

Feb 1995 - Mar 2000

Regulatory Affairs Manager

Rhône-Poulenc Rorer

Responsible for the local Regulatory Affairs Department (reporting to the G.M.), which involved:

• Management of all product registrations, for local and European procedures

• Management of pricing/reimbursement strategy and application procedures

• Coordination of Project Teams for the launch of new products and line extensions

• Support to Medical Dept. in the implementation of Clinical Trials/ Compassionate Use programs

• Supervision of promotional material review and approval procedures

• Support to manufacturing and QA activities for product compliance

• Cooperation in projects of the Corporate Socioeconomics Dept.

Feb 1989 - Feb 1995

Technical Director

Boehringer Mannheim Portugal

Qualified Person, with responsibilities for:

• Technical supervision of Pharmaceutical activity and Contract Manufacturing

• Registration procedures of pharmaceutical products including EU procedures

• Pricing and Reimbursement procedures for new and existing medicinal products

• Supervision of promotional Scientific Information and Marketing Code application

• Support to the Medical Dept. in the preparation and monitoring of Clinical Trials

• Cooperation with Marketing Dept. in training activities and New Projects evaluation

• Corporate Identity - Local coordination of a Corporate Identity development program

Dec 1982 - Jan 1989

Responsible Pharmacist

UCB Pharma

Qualified Person with responsibilities for:

• Technical supervision of Pharmaceutical activity and Contract Manufacturing

• Coordination of supply proposals for Hospital Tenders and Export Customers

• Registration procedures of pharmaceutical products

• Pricing and Reimbursement procedures for new and existing medicinal products

• Cooperation with Marketing Dept. in scientific training activities

• Product Management of a secondary product line

Education

Education
Oct 1996 - Jun 1997

Post-graduation

Catholic University of Portugal
Sep 1975 - Jul 1980

BSc, Pharmacy

Lisbon University - Faculty of Pharmacy

Skills

Skills

Languages

Fluent in Portuguese and English with additional language skills in French and Spanish

Information Systems

Good working knowledge of MS Office, MS Project and Internet software tools

EU Regulatory Procedures

Extensive practical knowledge of EU Regulatory Procedures and of EU Guidelines

Project Management

Large experience in the management of regulatory and development projects and significant teamwork capability

Certifications

Certifications

- Development of Management Competencies

Conceito O2 - 2005

- Introduction to Health Economics

Catholic University of Portugal - 2005

- EU Clinical Trials Directive

Aventis Pharma - 2004

- Introduction to Negotiation Skills

L&V Consulting - 2000

- Project Management Course (MS Project)

CEGOC - 1998