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Regulatory Associate

JOB PURPOSE

Regulatory execution of initiatives ensuring timely delivery/submission & product compliance according to current applicable legislation

 

SCOPE

Spain & Portugal

PRINCIPAL ACCOUNTABILITIES (Major end results the job is expected to achieve)

 

REGULATORY AFFAIRS

 

Ensure Regulatory delivery and execution of initiatives as well as product compliance across the business

  • Implementation of new legislation as required per market. Participate in regular compliance reviews with Trade Associations & other departments to provide stronger overall local governance. (CLP, biocides, banned substances)
  • Artwork & Product Information revision of NPD/EPD to ensure they fully comply with legislation. Minimize risk of recall due to labeling issues.
  • Global & Local database update to achieve excellent management of product license status. (PCS, GRAIS…)
  • Assessment of proposed advertising according to Spanish legislation and available claims.

QUALITY COMPLIANCE

 

Strengthen compliance across RB through delivery of key systems and processes. Working with other functions as appropriate to strengthen compliance across RB

 

  • QMS -Review and expand (as appropriate) the regulatory and medical components of the QMS; Successful audit of Regulatory elements of the QMS and regulatory support to ensure completion of corrective actions (SOP owner)
  • Support implementation of systems/processes updates as requited (Trackwise).
  • Maintain company distribution and import licences to ensure compliant activities
  • Batch release to market according to product category and according to QMS.

 

MEDICAL AFFAIRS

  • Proactively support the project teams, providing medical input and strategic advice to ensure the feasibility and success of product development initiatives throughout the launch procedure.
  • Provide medical information and advice in the development of promotional claims, ensuring that claims are medically accurate, fair, balanced and defendable in the event of a competitor challenge
  • Liaise with Marketing teams to maximize promotional claims
  • Provide medical support for claims substantiation on healthcare brands
  • Medical Scientific support: Support on medical & scientific responses to enquiries, including enquiries from healthcare professionals, regulatory authorities or consumers.

 

KNOWLEDGE AND EXPERIENCE

  • 2 years working experience in a regulatory affairs function in Healthcare, Pharmaceutical, industry.
  • Good understanding of regulatory & vigilance legislation and GMP requirements relevant to a regulated product
  • Strong interpersonal and communication skills.
  • Language skills – English, Spanish


Job Segment: Medical, Healthcare

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