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Senior Quality & Regulatory Affairs Associate, Middle East & India

Details
Full-time
On-site
Victoria, Australia
 

A bit about us  

If you are looking for a fantastic team and a challenging, fast, and dynamic work environment, you are at the right place!  

On our journey to making a positive difference across the world, you will work with passionate people in an innovative and collaborative organization as we inspire wellness through #PurposeLedCareers  

We are dedicated to our customers, community, and environment and are looking for similar-minded talent to join us! As an equal opportunity employer, we care deeply about creating an inclusive workplace where our team members feel valued, respected, and empowered.  

Our total rewards package offering includes additional annual leave, bonuses, wellness programs, health benefits, flexible and remote working arrangements, and performance awards - not to mention various social and recreational activities, all of which are regional specific.  

With over 3,400 team members working across the globe, our vision is focused on premium nutrition and lifetime wellness, backed by science. We have 3 business segments - Baby, Adult and Pet Nutrition and Care - supporting whole - family health and happiness across 7 international brands.

 

What this means for you 

The variety of work creates unlimited opportunities to excel across a breadth of disciplines; you will be presented with a wealth of new pathways and opportunities to explore throughout your career. Working with us will be more than just a job; we guarantee a life-changing experience as you step into an environment that moves quickly and presents new challenges daily.

 

Your role within the team 

We’re seeking a Senior Quality & Regulatory Affairs Associate to lead the Operational Quality Team and oversee product quality and regulatory compliance across the Middle East and India region (including India, Sri Lanka, Maldives, UAE, and SA). You will be the primary contact for product quality challenges, providing clear, compliant, and timely solutions. Additionally, you'll manage the ongoing stability program, including policy oversight, data reporting, and escalation of Out of Trend or Out of Specification results, in collaboration with the Product Development team. You will ensure timely batch releases, product compliance with quality standards, specifications, and agreements. Additionally, you'll review and approve product specifications and liaise with contract manufacturers to manage daily requests. As a member of the Quality Team, you will foster a culture of Continuous Improvement and Right First Time. You will support the Quality System Team in compliance to the PIC/S Guide of Good Manufacturing Practice for Medicinal Products on behalf of the Sponsor (Brand Owner). As the Regulatory lead in the region, you will be responsible for liaising with consultants and regulators to ensure compliance to the relevant regulations in each country. This includes, but is not limited to, reviewing and assessing formulations, ingredients, product labels, supporting evidence, advertising and marketing materials to ensure local regulatory requirements are complied with. Depending on the local requirements, this will include product registration with dossier creation and maintenance.

 

Key responsibilities include: 

  • Ensure timely and compliant release of all batches (including first batch approvals) to market, confirming that products meet required quality attributes and comply with industry standards, product specifications, and quality agreements. 
  • Ensuring all Quality aspects of NPD & EPD projects including the review and approval of:
    • Complexity assessments 
    • Provide Quality guidance on pre-commercial stability 
    • CM Briefs 
    • Bulk and Finished Product specifications 
    • Physical Sample review 
    • Manage and oversee the Stability Program, including ongoing stability activities and coordination with contract manufacturers 
  • Initiate Change Controls (where responsible) and approve Quality related actions of the Change Control System where required. 
  • Liaising with external labs for new areas of testing and managing accounts once established 
  • Liaising with strategic Suppliers/CM’s and manage scheduled ‘Quality Connects’ 
  • Ensure all Stock Returns are administered in the agreed time-frame. 
  • Prepare and review metrics for the Management Review. 
  • Organization of external contract testing (e.g., chemical, and micro testing) by approved Contract Testing Laboratories and management of samples and results provided by external laboratories. 
  • Notifying Quality Manager of significant quality challenges that may impact product quality or regulatory compliance (e.g. OOS, OOT), as well as key Quality and Compliance metrics. 
  • Auditing, due diligence visits and qualification of new suppliers/CMs and/or distributors/logistics service providers. 
  • Ensuring regulatory compliance of all products in each country, including product registrations where relevant 
  • Assessing product formulations, labels, marketing claims, evidence for compliance against local regulations 
  • Document management, ensuring all relevant regulatory documents are maintained 
  • Advising senior leadership of any compliance risks or challenges In addition, you will participate in: 
    • Mock Recalls 
    • The compilation of Product Quality Reviews for review by the Quality Manager. 
    • Robust and compliant documentation control (SOP’s / WI’s). 
    • New employee induction and where required ongoing training. 
    • Qualification of Suppliers through activities such as review of GMP/Quality Agreements. 
    • Good Documentation Practice (GDP) and Good Housekeeping Practice (GHP). 
    • Demonstrate the Swisse pledge for benchmark standards.

 

Desired Skills & Experience 

We look for people who have what it takes to make an impact; who can challenge us to go further while pushing themselves to deliver exciting & ambitious results.  

To make sure we’re setting new starters up for success, we ask that you meet a few criteria relevant to the role to be considered for this opportunity: 

  • High level Experience in the following areas: 
    • Pharmaceutical or Complimentary medicines manufacturing 
    • Investigation of Deviations and OOS’s using the Root Cause Analysis tools/disciplines and the implementation of Corrective and Preventative Actions. 
    • Time Management 
    • Product Quality Reviews 
    • Complaints Management 
    • Risk Management 
  • Additional Regulatory Experience: 
    • Has experience working in a regulated environment 
    • Has managed third party stakeholders, including regulators or government authorities 
    • Has a commercial focus and understanding relating to Regulatory decisions 
    • Has worked in a fast-paced commercial environment and can think on their feet 
    • Ability to assess risk and provide risk based regulatory advice to the business 
  • A relevant tertiary qualification in a Science or Engineering discipline or at least 5 years working in a similar pharmaceutical or regulated medical company.
  • Understanding of regulatory requirements for therapeutic and non-therapeutic products, including a working knowledge of Quality Systems, Risk Management and Compliance. 
  • Knowledge of Laboratory Operations 
  • Strong attention to detail with a commitment to accuracy, supported by proficiency in Microsoft Office (Word and Excel) and familiarity with Quality Management Systems.
  • Strong communication and organisational skills, with proficiency in written, verbal, and presentation abilities, as well as problem-solving, team building, planning, and decision-making 
  • The ability to analyse and critically asses’ information and provide guidance/advice based on your experience and information presented. 
  • Excellent stakeholder management and collaboration skills.

 

H&H Group believes in the benefits of a diverse & inclusive workplace & aims to reflect the varied cultures within which we exist. We are committed to providing a working environment that is free from discrimination & harassment, creating a safe and inclusive environment for all.  

We encourage applications from people of all ages, nationalities, religions, racial and gender identities, sexual orientations, abilities and cultures, & our hiring decisions will be based on business needs, position requirements, & the qualifications and experience of individuals. If you require support or assistance during the application process, please notify us at the time of application and we will be sure to enable reasonable adjustments where suitable.  

If you have what it takes, please apply via the online portal & we will be in touch soon. We move quickly & may fill the role prior to the application close date, so we suggest you get in touch today!

Apply now
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