Summary of Position:
- The QA & Regulatory Affairs Technical Writer supports projects related to business strategy in the space of sterile drug manufacturing including reactor and cyclotron derived new products.
- This position focuses on the creation, revision, and maintenance of technical documentation necessary for regulatory submissions and compliance within a regulated industry, such as pharmaceuticals, biotechnology, or medical devices.
- A keen attention to detail, strong writing skills, and the ability to synthesize complex information into clear, concise, and compliant documentation are essential.
Essential Functions:
• Draft, revise, and finalize technical documents required for regulatory submissions, ensuring compliance with local and international regulatory standards and • guidelines.
• Utilize technical writing strategies to ensure content of documentation is clear, concise, and complete.
• Work closely with subject matter experts (SMEs) across various departments to gather, interpret, and accurately represent data and information in regulatory documents.
• Participate in process and equipment testing to learn systems being documented.
• Review and edit technical documents for clarity, grammar, format, and compliance. Ensure all documentation is accurate, up-to-date, and adheres to established standards and SOPs.
• Manage the lifecycle of regulatory documents, including version control, archiving, and retrieval. Ensure the integrity and confidentiality of sensitive information.
• All programs must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
Must Haves:
1) Bachelor’s or Master’s Degree in Life Science
2) 3+ years of relevant QA or Regulatory Technical Writing
3) Strong experience with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems.
Plus:
1) Method development/validation experience
2) Working knowledge of cGMP regulations and guidelines and their application in a controlled aseptic environment is strongly preferred
3) Any radiopharma experience is highly valued
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
