Main characteristics
- Location
- Melbourne, Victoria
- Company
- Randstad
- Salary
- AU$ 600 - AU$ 700 /per day
- Employment type
- Permanent
- Category
- healthcare & medical
Job summary
job detailsJoin our client, a dynamic pharmaceutical company, as a Regulatory Affairs Manager responsible for providing regulatory support for their manufactured products in the Asia Pacific markets. This specialised role is part of the Global Regulatory Affairs team.
...
Perks:
- 6-month contract with potential extension
- Competitive rate: $650 per day
- Flexible work arrangement: 1-3 days at the office, with the remaining days working from home
Primary Duties:
- Actively contribute to and support the regional regulatory strategy for manufactured products
- Assist in crafting regulatory submissions that adhere to content requirements for applicable territories, including negotiations with relevant Health Authorities
- Participate in the preparation and submission of marketing applications, variations, renewals, and responses to inquiries
- Manage regulatory agency correspondence and submissions within relevant databases, ensuring regulatory compliance
- Assist in maintaining updated product labelling for all relevant territories, including translation requirements
- Establish and nurture strong, collaborative relationships with Regulatory Agencies
Qualifications for Success:
- Regulatory affairs experience in the pharmaceutical manufacturing industry
- Previous experience negotiating with local Health Authorities and driving regulatory submissions, including marketing authorisation applications, to approval
- Excellent communication skills
- Established positive relationships with local Health Authorities
- Highly developed organisational skills, including planning and time management
- Strong problem-solving and analytical skills with meticulous attention to detail
At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.
show more
Join our client, a dynamic pharmaceutical company, as a Regulatory Affairs Manager responsible for providing regulatory support for their manufactured products in the Asia Pacific markets. This specialised role is part of the Global Regulatory Affairs team.
Perks:
- 6-month contract with potential extension
- Competitive rate: $650 per day
- Flexible work arrangement: 1-3 days at the office, with the remaining days working from home
Primary Duties:
- Actively contribute to and support the regional regulatory strategy for manufactured products
- Assist in crafting regulatory submissions that adhere to content requirements for applicable territories, including negotiations with relevant Health Authorities
- Participate in the preparation and submission of marketing applications, variations, renewals, and responses to inquiries
- Manage regulatory agency correspondence and submissions within relevant databases, ensuring regulatory compliance
- Assist in maintaining updated product labelling for all relevant territories, including translation requirements
- Establish and nurture strong, collaborative relationships with Regulatory Agencies
...
Qualifications for Success:
- Regulatory affairs experience in the pharmaceutical manufacturing industry
- Previous experience negotiating with local Health Authorities and driving regulatory submissions, including marketing authorisation applications, to approval
- Excellent communication skills
- Established positive relationships with local Health Authorities
- Highly developed organisational skills, including planning and time management
- Strong problem-solving and analytical skills with meticulous attention to detail
At Randstad, we are passionate about providing equal employment opportunities and embracing diversity to the benefit of all. We actively encourage applications from any background.
show more
- skills
Regulatory affairs experience in the pharmaceutical manufacturing industry
- qualifications
- Bachelor of Science or relevant qualification
- education
Bachelor Degree
Inform me about similar jobs: