Regulatory Affairs Officer

Publicado 23 Maio 2020

GSK

Lisboa (Publicidade / Marketing)


Site Name: Lisbon
Posted Date: May 22 2020

At GSK Portugal we are looking for a Regulatory Affairs Officer:

Job Purpose

  • Registration of new products, maintenance of licenses and ensure regulatory compliance

Key Responsibilities

primary deliverables of the role; it's scope

  • Prepares and submits dossiers to the Portuguese Health Authorities in order to obtain the authorization of commercialization of new medicines.
  • Prepares communication to the Portuguese Health Authorities/key stakeholders for medical devices and cosmetics.
  • Manages renewals for licensed products & variations required after medicines launch.
  • Manages new product launches & variation implementation projects.
  • Elaborates SmPC, leaflets and artworks according regulatory requirements, in coordination with marketing.
  • Revises and approves artworks according to local regulatory requirements.
  • Provides regulatory input and support for advertising campaigns and promotional materials.
  • Works with Global Regulatory Affairs Team to coordinate the submission of dossiers.
  • Provides Marketing/Business support with RA strategic information on new products & competitors
  • Ensures an intensive awareness of all relevant current medicines, cosmetics and medical device legislation in Portugal and Europe.
  • Ensures support to Local Business and Global RA on regulatory strategy & claims
  • Compliance with internal processes and procedures and maintenance of key data bases.

Requirements

Minimum of 2/3 years of relevant experience in the pharmaceutical industry.

Previous experience in OTCs industry is a plus

Strong communications, negotiation and problem-solving skills.

Computer literacy in Microsoft Office & regulatory applications.

Good knowledge of Portuguese pharmaceutical, cosmetic and medical device legislation.

Good knowledge and relationship with Health Authorities

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK?s compliance to all federal and state US Transparency requirements. For more information, please visit GSK?s Transparency Reporting For the Record site.