Regulatory Affairs Associate

Blackmores (www.blackmores.com.au) is Australia’s No.1 vitamin and dietary supplements brand with a legacy of over 90 years and is a publicly listed company employing 1250 people in 11 markets across Asia-Pacific. Headquartered in Australia, Blackmores has its international headquarter in Singapore, a health Innovation Centre in Shanghai, and a state-of-the-art manufacturing facility in Australia.

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

Purpose of role:

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.
• Implement strategies for minimising regulatory approval times.
• Implement strategies to negotiate successful regulatory approvals.
• Proactively identify, correct, and resolve compliance issues.
• Ensure regulatory information is effectively communicated to business stakeholders.
• Ensure good inter-departmental engagement with business stakeholders.
• Maintain relevant product databases.
• 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.
• Build and develop relationships with key regulators, industry organisations and key market regulatory contacts.
• Representing Blackmores in industry committees and associations
• Participate in seminars and industry events to build profile and rapport with key stakeholders

Who are you?

• Relevant pharmacy or science/nutrition qualification
• A minimum of 3 years’ experience in HSTM category
• Strong working knowledge of regulated environments
• Strong relationships with relevant regulatory agencies, industry and government bodies
• 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
• Knowledge of industry trends, developments and best practices
• Ability to develop strong internal and external partnerships

Agencies please 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