Regulatory Affairs Director jobs in Indiana

Summary of Position

The Regulatory Affairs Technical Writer supports projects related to Curium’s 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.).
  

Requirements

• Bachelor Degree or equivalent work experience required.
• 3 or more years of relevant experience in technical writing required.
• Experience with technical writing in a regulatory affairs environment preferred.
• Experience in the pharmaceutical, biotechnology, or medical device industry is highly preferred.
• Must be able to communicate clearly in English and have solid communication skills including grammar and composition.
• Demonstrated understanding of GMP / cGMP regulations.
• Skill in communication, written and verbal with the ability to interact with cross-functional teams.
• Proven time management skills and a strong attention to detail.
• Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
• Ability to work well with others and independently.
• Able to read, understand and follow work instructions in a safe, accurate and timely manner.
• Proficiency in document management systems and Microsoft Office Suite. Familiarity with eCTD structure and requirements is desirable.

Working Conditions

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8 hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.