Regulatory Affairs Associate

Malaysia, Malaysia

Job Description

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Blackmores ( www.blackmores.com.au ) is Australia\xe2\x80\x99s No.1 vitamin and dietary supplements brand with a legacy of over 90 years and is a publicly listed company employing 1250 people in 13 markets across Asia-Pacific. As a purpose-led, performance-driven organisation, Blackmores Group strives to create remarkable employee experiences through supporting a diverse and inclusive culture, creating leadership that inspires high performance, and providing everyone with opportunities to achieve their professional, personal and wellbeing goals supported by our flexible work practices and family friendly policies. Blackmores Group operates in 12 markets, with global headquarters in Sydney, Australia an international HQ in Singapore, an Innovation Centre in Shanghai and a state-of-the-art manufacturing facility in Victoria, Australia. Purpose of role A trusted business partner for regulatory matters. This role will oversee Blackmores products and regulatory market compliance in Malaysia and Singapore. NPD/ EPD project management, product pre-market approvals and post-market activities compliance (including but not limited to advertisement/ sales promotion permit) in Malaysia and Singapore. Responsibilities include:
  • Provide regulatory advice on the registration pathway of new product formulations.
  • Submit pre-market approval application according to agreed filling plan.
  • Review and approve advertising, promotional materials, and scientific/technical/evidence file product information to ensure compliance with local regulations.
  • Approve all product labelling for compliance to regulations.
  • Proactively identify, correct, and resolve compliance issues.
  • Ensure regulatory information is effectively communicated to business stakeholders.
  • Keep up to date on regulatory changes and ensure on-going compliance.
  • Ensure responses to post-market compliance reviews are managed and completed within expected timeframes.
  • Implement strategies for minimising regulatory approval times.
  • Implement strategies to negotiate successful regulatory approvals.
  • Participate and represent Blackmores in seminars and industry to build profile and rapport with key stakeholders.
Who are you:
  • Minimum a Bachelor\xe2\x80\x99s degree holder of relevant pharmacy or science/nutrition qualification
  • A minimum of 3 years\xe2\x80\x99 experience in HSTM category or related fields
  • Strong working knowledge of regulated environments includes with regulatory agencies and government bodies
  • Good in analysis method and problem-solving skills
  • Fast moving, solution driven with a good track record of successful execution of commercial and compliant solutions
  • Sound knowledge of manufacturing and quality controls and Good Manufacturing Practice
  • A passion for the Natural Health industry
Agencies note: this recruitment assignment is being managed directly by Blackmores Talent Acquisition team. We will reach out to our preferred agency partners if required. Your respect for this process is appreciated.

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Job Detail

  • Job Id
    JD911611
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Malaysia, Malaysia
  • Education
    Not mentioned