Regulatory Affairs Manager

Scitex Recruitment

Excellent opportunity for a Regulatory Affairs expert from Pharma/Health product background experienced in FDA/Medsafe/TGA

  • Internationally renowned Healthcare products
  • Global Regulatory Systems expert with a pharma/health product background
  • Flexible working, can live in Auckland & work in BOP 1-2 days

The Company 

Our clients are a market leading company who have gained international recognition for their healthcare products through a commitment to quality,  excellence and sustainability. Proudly NZ owned, they are an excellent example of 'kiwi entrepreneurship', promoting and selling the NZ Brand across global markets including USA, UK, Australia and Asia. 


The Role

We are seeking an experienced Regulatory Affairs Manager to manage the company’s Global Regulatory Portfolio. You will be responsible for driving regulatory best practices by designing and executing strategies to support business growth and global marketing activities. You will also:
  • Ensure the company complies with global regulations relating to all products and markets.
  • Liaise with key stakeholders to satisfy regulatory requirements, manage product risks, achieve and maintain product registrations that support the sale of company products across international markets.
  • Management and ownership of company product safety and maintenance of pharmacovigilance best practice and policy.
  • Support the marketing, operations, innovation teams & other stakeholders in reviewing all regulatory requirements for both new product development and continuous improvement initiatives.

Skills and knowledge
  • Tertiary qualifications ideally to Master level and/ or additional training
  • Minimum 3-5 years’ experience within a highly regulated Pharmaceutical/health supplement or associated sector.
  • Experienced in preparing submissions, maintaining regulatory licensing (Medsafe / TGA / FDA, CBEC) and international market access requirements.
  • Knowledge of Quality Management Systems
  • Strong familiarity with scientific studies, product safety requirements and pharma/dietary supplement manufacturing and distribution.
  • Excellent communication skills - written and verbal, where you are comfortable communicating across all levels of organisation.
  • A  'hands on' leadership style, self-motivated and proactive attitude.
  • Organised, pro-active and flexible; with a high level of attention to detail.

Benefits 
  • Flexible working with the option of living in Auckland and working 1-2 days/week in Bay of Plenty.
  • Great company culture, highly motivated team driven to succeed and help each other on this exciting journey!
  • Excellent salary package 

How to apply

Please confidentially present your CV, with your achievements and a covering letter or call Pavan at +64 9 525-5520 quoting reference number 11/2103/PB for a confidential discussion. All applications will be treated in the strictest of confidence.

To apply for this vacancy you MUST be a New Zealand citizen, resident, or have already secured the right to work in New Zealand and therefore hold a valid visa.

Scitex specialises in permanent, contract and temporary recruitment - and has done since 1987. We are here to engineer better Mondays. We love connecting talented people with great work opportunities in workplaces where you can thrive and make a meaningful difference.