Summary
Overview
Work History
Education
Skills
Languages
Timeline
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Marta Felices Granados

Marta Felices Granados

Summary

  • Pharmacist with more than 15 years of experience in Consumer Health/OTC products in pharmacies and the pharmaceutical industry.
  • Specialized in developing and implementing regulatory strategies efficiently in Iberia, other European countries, LATAM, MENA and Asia and for leading a professional team focused on ensuring the technical and scientific support to the business areas of the company. For the last few years, I have also been responsible for food supplements, cosmetics and medical device development.
  • From 2013 to the present, I took part of cross-functional teams due to merger by acquisition between different specializing OTC product companies, leading the technical integration part, and garnering extensive organisational skills accordingly. In terms of my skills, I also emphasise strategic thinking and teamwork. Highly-motivated and strongly committed to my work, determined, assertive, communicative, persuasive, proactive and encouraged to make the most of the challenges.

Overview

21
21
years of professional experience

Work History

Head of Consumer Health Department

Kern Pharma, S.L.
Terrassa
05.2021 - Current
  • Regulatory Affairs and R&D Manager (food supplements, cosmetics, medical device, biocides). Mainly responsible for making sure that products are developed, manufactured and commercialised according to the applicable current legislation.
  • Lead and coordinate a team of 5 members responsible for the technical and regulatory activities required for both product launch and life cycle, ensuring compliance with the applicable regulations.
  • Data analysis to incorporate new products or propose product reformulations in the portfolio based on market trends, resulting in the development of new products and launches.
  • Implementation of strategies to align the department's activities with the company's business areas.
  • Support to Medical Affairs, such as the review of advertising materials and obtaining prior authorizations, training to sales force, pharmacies and healthcare professionals, and responding customer and delegates queries.
    Responsibilities:
    - Define and execute the development and the most appropriate regulatory strategy to incorporate a new product into the company's portfolio.
    - Design and approve formulations for new own developed products and reformulations during their life-cycle, ensuring extensive scientific evidence and regulatory compliance.
    - Keep up to date and develop in-depth knowledge of the regulations, requirements and registration procedures at local and international level, as well as on scientific progress and innovation.
    - Advise, coordinate, compile and submit registration dossiers, variations and renewals to local and international regulatory authorities (Europe, LATAM, MENA and Asia), of own developed products or licensing from other companies, acting as a link between the company and corresponding stakeholders.
    - Ensure that product labelling and consumer information comply with current legislation.
    - Scientific, technical and regulatory support on commercial and business strategies.
    - Transverse support to quality and supply chain areas.

Regulatory Affairs Officer

Kern Pharma, S.L.
Terrassa
04.2014 - 05.2021
  • Submission of registration dossiers (eCTD) of generic medicinal products to the national regulatory authority (AEMPS), of own developed products and licensing from other companies (national, mutual recognition and decentralized procedures).
  • Negotiate with the national regulatory authority (AEMPS) for marketing authorisations.
  • Maintenance of approved dossiers through variations and renewals submissions to the national regulatory authority (AEMPS).
  • Be up-to-date with the national and European regulatory requirements, guidelines and registration procedures.
  • Perform different regulatory activities related to other OTC products such as food supplements, biocides, cosmetics and medical device.
  • Prepare and review product labels, patient information leaflets and summary of product characteristics.

Regulatory Affairs Internship

Kern Pharma, S.L.
Terrassa
04.2013 - 03.2014
  • Transverse support into the department (specifically to National and CMC units) in preparing the technical documents of module 3 and module 1 CTD related to new registration applications (launches) and variations to optimize manufacturing processes and/or analytical methods.

Quality Responsible

Farmacia Mª Dolors Ros Casanovas
Castellar Del Vallés
02.2008 - 12.2012
  • Managing Director Representative and Quality Responsible for ISO standard 9001.

Management Trainee - Sales and Strategies

Farmacia Rosa Mª Carrera Grañó
Sabadell
03.2003 - 02.2008
  • Direct and coordinate products, services and sales activities.
  • Cultivate strong professional relationships with suppliers to drive business.
  • Support team members to drive growth and development.
  • Coach, develop and motivate team to achieve revenue goals.

Education

Master's Degree - Business Management For Pharmaceutical Industry

Centro De Estudios Superiores De La Industria Farmacéutica (CESIF)
Barcelona, Spain
06.2013

Postgraduate Degree - Orthopedics

Universidad Internacional De Cataluña (UIC)
Barcelona, Spain
06.2004

Bachelor's Degree - Pharmacy

Universidad De Barcelona (UB)
Barcelona, Spain
03-2003

Skills

  • Technical: Regulatory compliance, Quality System (Change Control and CAPA)
  • Strategic thinking
  • Team building and management
  • Organisation and time management

Languages

Spanish and Catalan
First Language
English
Upper Intermediate (B2)
B2
German
Beginner
A1

Timeline

Head of Consumer Health Department

Kern Pharma, S.L.
05.2021 - Current

Regulatory Affairs Officer

Kern Pharma, S.L.
04.2014 - 05.2021

Regulatory Affairs Internship

Kern Pharma, S.L.
04.2013 - 03.2014

Quality Responsible

Farmacia Mª Dolors Ros Casanovas
02.2008 - 12.2012

Management Trainee - Sales and Strategies

Farmacia Rosa Mª Carrera Grañó
03.2003 - 02.2008

Master's Degree - Business Management For Pharmaceutical Industry

Centro De Estudios Superiores De La Industria Farmacéutica (CESIF)

Postgraduate Degree - Orthopedics

Universidad Internacional De Cataluña (UIC)

Bachelor's Degree - Pharmacy

Universidad De Barcelona (UB)

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Marta Felices Granados