Regulatory Affairs Associate
Regulatory Affairs Associate
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Job Description
The Regulatory Affairs Associate ensures compliance with regulatory guidelines and requirements for the development registration and maintenance of pharmaceutical medical device and other healthcare products in Australia and New Zealand. Working with our Aesthetics business the associate will work closely with internal departments regulatory authorities and external stakeholders to support product registration submissions and ongoing regulatory compliance activities.
This is a 12 month contract position.
KEY DUTIES AND RESPONSIBILITIES
- Monitor and interpret Australian and New Zealand regulatory requirements and guidelines for pharmaceutical medical device and other healthcare products and update internal stakeholders on relevant changes impacting product registrations and compliance.
- Coordinate and compile necessary documentation for regulatory submissions ensuring accuracy completeness and timeliness.
- Submit regulatory submissions including product registrations variations renewals and responses to regulatory requests.
- Collaborate with crossfunctional teams to provide regulatory guidance and support for product development labeling and marketing activities.
- Assist in maintaining regulatory records across Regulatory Information Management (RIM) platforms for assigned product portfolio in compliance with local and global procedures to ensure accurate and uptodate information.
- Prepare and maintain regulatory documentation including prescribing information packaging materials and instructions for use in compliance with applicable regulations.
- Act as a liaison with regulatory authorities fostering positive relationships and representing the companys interests during meetings.
- Participate in internal and external audits to ensure compliance with regulatory requirements and quality management systems.
- Support the commercialisation of products through participation in local brand teams
- Participate in/coordinate special project assignments as determined by the Director of Regulatory Affairs or Regulatory Affairs Manager/Sr Manager
- Report any adverse event within 24 hours as per AbbVies policies and procedures.
- Proactively participate in AbbVies WHS programs adhere to policies and promote a safe work environment at all times.
- Adhere to AbbVies internal codes of conduct and compliance processes.
- Other ad hoc duties such as administrative duties as requested.
Qualifications :
- Bachelors degree in a scientific discipline or related field.
- Experience with TGA (Therapeutic Goods Administration) and Medsafe (Medicines and Medical Devices Safety Authority) regulations (GMPGood Manufacturing Practices) guidelines and processes.
- Minimum 2 years experience within a similar regulatory role within the healthcare industry. Medical Devices experience desired.
- A commercial focus and a desire to contribute to the overall success of the business
- A high level of integrity and ethical conduct ensuring compliance with regulatory and company policies
- Ability to work autonomously as well as part of a crossfunctional team with a proactive and collaborative approach
- Well organized with an ability to meet deadlines and achieve goals
- Detailoriented with strong organisational and project management skills.
- Strong analytical and problemsolving skills with the ability to assess regulatory risks and propose appropriate solutions.
- Knowledge of quality management systems GMP (Good Manufacturing Practices) and ISO standards (as appropriate).
- Ability to work in a high paced environment
- Excellent oral and written communication skills
- Excellent attention to detail and time management
- Good proficiency for Microsoft Office (Word Excel PowerPoint)
- Proficiency in using regulatory databases document management systems and other relevant software tools
- Willing to learn adaptable to change proactive and responsive
Flexibility and Availability: In line with Australias Right to Disconnect legislation we recognise and respect employees right to refuse contact outside of their working hours unless such refusal is deemed unreasonable. As we operate in an international matrixed environment there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.
Additional Information :
WAYS WE WORK
- All For One Abbvie; We weigh all decisions against the common good. We inspire share and create as a team. We solve problems for all rather than serving our immediate team.
- Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly embrace experimentation and learn what doesnt work and get on to what does.
- Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results staying keenly aware of the urgency in all we do.
- Clear & Courageous; Open honest candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
- Make Possibilities Real; We question with endless curiosity. Were never satisfied with good enoughpatients depend on us to deliver more. We challenge ourselves to find creative constructive solutions to turn possibilities into reality.
CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT
- AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers with each other business partners and suppliers.
- AbbVie as a responsible corporate citizen will adhere to these standards as well as to local national and international laws.
- All AbbVie employees are responsible for maintaining the Companys reputation for conduct in accordance with the highest level of business integrity ethics and compliance with the law. Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal.
- AbbVie is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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US & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
