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Regulatory Affairs Specialist

4 months ago

Melbourne, Australia Bell People Consultants Full time

Global Pharmaceutical Manufacturing Organisation
- Regulatory Support for Products within Asia Pacific Markets
- Melbourne Metro Area - Hybrid Role - WHF & Site based

**About the Company**:
Operating as a progressive and highly respected pharmaceutical manufacturing organisation, our client is well known for its operational excellence, passion for innovation and its quality branded products.
Due to rapid growth in its operations, an opportunity has now arisen for a
**Regulatory Affairs Specialist** to provide regulatory support for manufactured products within the Asia Pacific Markets.

**About the Opportunity**:
Reporting to the Senior Director, key duties include the following:

- Actively support the implementation of regional regulatory strategy for manufactured products including product development.
- Provide regional expertise to ensure dossiers & regulatory submissions meet content requirements for applicable territories.
- Ensure all regulatory agency correspondence & submissions are managed within databases & tracked to regulatory compliance.
- In collaboration with Global Strategic Labelling, assist in up to date product labelling for all territories including translation requirements.
- Establish & maintain strong & collaborative working relationships with regulatory agencies across the Pacific Region.

**About You**:

- Tertiary qualifications in Biological Science, Allied Medical Discipline or Pharmacy.
- Masters or PhD is highly desirable.
- Sound experience in pharmaceutical/biotechnology industry essential.
- Minimum of 7 yrs experience in regulatory affairs in Asia Pacific Area.
- Previous experience in working with global corporations comprising range of different functional areas & cultures.
- Strong customer focus.
- Excellent interpersonal and communication skills.
- Highly developed organisational skills including planning & time management.
- Ability to liaise effectively with all internal & external stakeholders.

**Culture & Benefits**

**This is an Excellent Opportunity for a Regulatory Affairs Specialist **to join a global pharmaceutical company & provide regulatory support for pharmaceutical manufactured products within the Asia Pacific Region.

**This is a Melbourne Based Opportunity and is a HYBRID role offering WFH & Office Based Flexibility.**

**How To Apply**

To applly for the position, please click APPLY below below.

For confidential discussion, please contact Maria Julienne on 0491 694 371 or Sue Campbell on 04147 994 917.