Senior Specialist - Regulatory Affairs

at  Advanz Pharma

ABOUT YOU

We are looking for highly motivated individuals who are passionate about making a meaningful difference to patients’ lives.
For this role, you will also have the following:

Qualifications:

• Formal Training in Regulatory Affairs.
• Graduate in any discipline of science, preferably life science / Pharmacy or Post-Graduate in Regulatory Affairs.

KNOWLEDGE, SKILLS & EXPERIENCE:

• Significant experience in Regulatory Affairs, including expertise in Prescription medicines in a highly regulated market.
• A sound understanding of regulations, guidelines and policies relating to prescription medicines.
• Previous experience with TGA and Medsafe
• Experience in Regulatory Affairs for OTC and complementary medicines and devices
• Experience in Quality Assurance activities.
• Experience in electronic submissions.
• Should be a natural with Relationship building, Mentoring, managing change and possess decent Commercial acumen.
• Good Project Management and Communication skills.
• Pleasant personality with collaborative approach, interpersonal skills, high on team spirit
• Demonstrate sense of drive and urgency through work.
• Be able to take decisions based on facts available, trend and suggest solutions to line manager (solution oriented).
• A positive and ‘can-do’ approach, biased towards finding solutions and embracing change.
• Inspired by our values of entrepreneurship, speed and integrity.
• Learning agility and ‘scalability’, with a desire to continuously improve and develop as ADVANZ grows.
• Work collaboratively across all business functions with an open, honest, and respectful cooperation.
• Ability to have fun and thrive in a growing, unique, and inclusive work environment.

ABOUT THE ROLE

As ADVANZ PHARMA continues to strengthen its position as the partner of choice for specialty, hospital, and rare disease medicines, we have an exciting opportunity for an Sr. Specialist Regulatory Affairs.
Main purpose of the job is to ensure adequate and prompt life cycle maintenance activities for Marketing Authorization’s (MA) held by ADVANZ PHARMA based on portfolio assigned with a focus on supply continuity and compliance with regulatory requirements.