Regulatory Affairs Specialist

4 weeks ago

Tennant Creek, Australia Innomar Strategies Full time

At Innomar Strategies, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for coordinating and compiling regulatory submissions, responses to agency questions, and other correspondence in accordance with requirements for assigned projects.

Key Responsibilities:

  • Coordinate and compile regulatory submissions, responses to agency questions, and other correspondence in accordance with requirements for assigned projects.
  • Participate in cross-functional teams to support regulatory strategies and help achieve business results.
  • Identify client and dossier issues and develop effective strategies to address them, consulting with others as needed.
  • Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with clients/agencies.
  • Prioritize and monitor assigned projects to meet budget, timelines, and client expectations, identify and communicate emerging issues.
  • Support client proposals and new business activities as assigned.
  • Ability to travel as necessary, passport required.

Requirements:

  • B.Sc. (advanced degree preferred) in Life Sciences (Microbiology, Biology, Chemistry, or Pharmacy preferred) or extensive equivalent experience and related training.
  • Certification in Regulatory Affairs (RAC) and other relevant certifications an asset.
  • Prior consulting experience an asset.
  • 5+ years Regulatory Affairs or related relevant experience within the health care products industry, or consulting.

Skills and Knowledge:

  • Direct experience and working knowledge of a wide range of regulatory submission types.
  • Strong working knowledge of local Health Authority regulations, guidelines, and policies.
  • Effective time management and multi-tasking skills.
  • Demonstrated strategic planning and problem-solving skills to resolve issues effectively and efficiently.
  • Strong business and financial acumen.
  • Strong analytical and mathematical skills.
  • Effective organizational skills; attention to detail.
  • Ability to consistently meet deadlines.
  • Ability to communicate effectively both orally and in writing.
  • Demonstrated ability to work in a cross-functional, multi-disciplinary team environment.
  • Knowledge of computers, to operate effectively with Adobe Acrobat, Microsoft Word, Excel spreadsheets, and Microsoft Outlook.

What We Offer:

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness.

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