Senior Regulatory Affairs Associate at Blackmore_Career_Site_New

, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

07 Jul, 26

Salary

0.0

Posted On

08 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory affairs, Product registration, Regulatory strategy, Compliance management, Project management, Stakeholder management, Data analysis, Regulatory relations, TGA guidelines, Product labeling, Commercial acumen, Interpersonal communication, Written communication, Regulatory compliance, Process enhancement

Industry

Wellness and Fitness Services

Description

We are hiring for a Senior Regulatory Affairs Specialist to join our Regulatory Affairs, ANZ team. Purpose: This role plays a pivotal role in driving Blackmores' innovation and growth through effective regulatory management, leveraging commercial acumen to gain a competitive edge within TGA guidelines. This role will be responsible for drafting, submitting and managing product registrations for all product classifications, including registered medicines. This role reports to the Director of ANZ Regulatory Affairs and will be expected to work out from our Warriewood, NSW site at least 4 days per week and 1 day from home. Responsibilities include: * Develop and implement regulatory strategies for product registrations and compliance, ensuring minimized approval times and successful regulatory outcomes. * Manage submissions and product registrations for all product classifications that also include new ingredient listing. * Foster and maintain relationships with regulatory bodies, including the TGA, to stay informed about regulatory changes and ensure compliance. * Identify opportunities for process enhancements and implement changes to improve regulatory compliance, reduce cycle times, and increase efficiency. * Collaborate with cross-functional teams to ensure effective communication and regulatory compliance. * Maintain relevant product databases and ensure accurate product labeling. * Proactively identify, correct, and resolve compliance issues, and manage responses to post-market compliance reviews. What we offer? * A role that will manage product registration and submission as an independent contributor. * Great benefits to support your health and wellbeing, including access to discounted products * Mental health support for you and your family through our Sonder assistance program Who are you? * Bachelor's degree in Science, Pharmacy, or a related field. * Minimum 5 years and more of experience in regulatory affairs, with a focus on project management and regulatory relations. * Strong understanding of regulatory requirements and guidelines (e.g., FDA, TGA, Medsafe). * Excellent interpersonal communication and stakeholder management skills * Strong analytical skills with the ability to interpret data, generate insights, and support commercial decision-making. * Excellent verbal and written communication skills, with the ability to present insights and influence stakeholders. Blackmores Group is a leading natural health company with proud Australian heritage, with extensive reach across Asia Pacific. Founded by visionary naturopath Maurice Blackmore in 1932, our vision is to connect every person on earth to the healing power of nature by combining our knowledge of nature and science to deliver quality health solutions to people and their pets everywhere, every day. Blackmores Group operates in over 12 markets, with headquarters and a state-of-the-art manufacturing facility in Australia, and offices across South East Asia and China. 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.

Responsibilities

The role involves developing and implementing regulatory strategies to manage product registrations and ensure compliance with TGA guidelines. You will also foster relationships with regulatory bodies and collaborate with cross-functional teams to drive innovation and efficiency.