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Spclst, Regulatory Affairs Job

Date: Nov 10, 2017

Location: Lisbon, PT

Company: MSD

Requisition ID: REG003397

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD’s Animal Health (MAH) division works to improve the health of animals around the world through collaborative partnerships and a deep sense of responsibility towards our customers, consumers, animals, society, and our planet. This team of energetic, independent thinkers offers one of the industry’s most innovative portfolios of products, services, and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species both domestically and internationally.

Full-time, permanent position in MSD Animal Health Regulatory Affairs Department.

Functional responsibilities include but are not limited to:
  • Manages regulatory processes for new Marketing Authorisations and maintenance of Marketing Authorisations, including timely preparation, submission and appropriate follow-up of new Marketing Authorization applications and timely submission of variations, renewal applications and supplemental marketing authorizations.
  • Ensure the operational activities on ARTIS related to artwork development
  • Ensures compliance with local regulatory requirements & MSD Animal health policies and standard operating procedures 
  • Manages EU certificate request to Competent Authorities
  • Regularly interacts with DGAV regarding product related activities and EU certificate emissions
  • Manage the database of all veterinary medicinal products, packaging materials, EU certificates. 
  • Maintains a positive relationship with internal and external regulatory contacts & other stakeholders 
Qualifications

Education:
  • University degree in Pharmaceutical Sciences or Veterinary Medicine
Experience:
  • Minimum of 1-2 years’ experience in regulatory affairs (preference), quality or medical 
Skills:
  • Ability to communicate well verbally and in writing with internal and external stakeholders
  • Proactivity & problem solving mindset
  • Good organizational and planning skills
  • Attention to detail and ability to meet predefined deadlines
  • Flexibility to successfully handle conflicting time pressures and manage priorities
  • Portuguese knowledge (native level) & English knowledge (proficiency level)
  • Excellent PC use skills with regard to word-processing, spreadsheets, database application, and internet.
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.



Job: Regulatory Affairs Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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