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| POSITION DESCRIPTION | AUSTRALIAN BIOTECH INDUSTRY MARCH 2009 |
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Regulatory Affairs Manager |
| Position Code: | 65 | | Career Level: | 5 |
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Responsible for
Establishing standards and specifications for all organisational products that have to comply with Government Regulations and advising and guiding programmers to ensure the approval of such products to market. |
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Reports To
Chief Executive Officer, Technical Manager. |
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Supervises
May supervise a small team of Regulatory Affairs Officer(s). |
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Main Activities
Ensuring that all new and existing products are registered correctly with the relevant Government Authorities.
Planning, preparing and submitting submissions to the relevant Government Regulatory Authorities on product specifications and ensuring the timely approval of product applications.
Preparing clinical trial applications for early phase clinical trials and drafting associated clinical protocols.
Advising on key strategic issues such as the design and timing of toxicology and clinical studies and ensuring they comply with the latest guidelines.
Responding to questions raised by the Regulatory Authorities during their assessment of submissions.
Recommending changes to product specifications in line with statutory requirements.
Maintaining existing registrations (licence maintenance) keeping the relevant regulatory authorities informed of changes to approved products - such as how it is made or prescribed and monitoring and arranging necessary re-registration.
Meeting with relevant regulatory authorities as required.
Assisting in training Sales Staff.
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Key Skills
Ability to meet deadlines and deal with Government Agencies.
Good communication skills and attention to detail.
The ability to understand and summarise complex scientific information.
Presentation and negotiation/persuasion skills.
Proven track record in medical writing.
Knowledge of Food & Drug Administration (USA) and Therapeutic Goods Administration (AUS) regulatory requirements.
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Internal Contacts
Company Secretary, Legal Officer, Scientists, IP Staff. |
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External Contacts
Commonwealth & State Government Officials, Regulatory Authorities, Clinical Scientists. |
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Typical Experience
Will have at least 5 - 10 years of related experience coupled with relevant tertiary level qualifications in a Scientific or Technical field. May also possess higher qualifications such as a related MSc or PhD. |
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Other Comments
In smaller companies Regulatory Affairs may be combined with other project management responsibilities such as Quality Assurance. |
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