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Regulatory Affairs Scientist - Global HealthTechnologies

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Social Sciences Research
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SSES TKIP
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200UE Requisition #

RTI International is currently seeking a Regulatory Affairs Scientist with a background and interest in clinical regulatory activities as it relates to biopharmaceutical development.  The primary responsibility of this position will be to provide regulatory guidance, supplemental writing, and review of clinical reports and pertinent regulatory submission sections for drugs, biologics, or diagnostics development projects.  This individual will fulfill a key role with a focus on clinical affairs as a member of a team of scientists in RTI’s Global Health Technologies group working to develop new products to address critical unmet global health needs and opportunities.

 
Responsibilities:
  • Plan and oversee regulatory activities for drug development; provide expertise and strategy, to multi-functional project teams as a regulatory contact.
  • Provide regulatory assistance or serve as FDA regulatory contact for clients.
  • Write and support the preparation of regulatory documents required to support clients' global drug development and registration activities.
  • Serve as the medical writing representative on assigned product teams and closely collaborate with personnel from clinical, regulatory, and scientific departments. 
  • Manage the regulatory submission process and regulatory agency interactions with a regulatory team.
  • Working with a project coordinator, ensure maintenance of each product development program’s applications and documentation, per regulations.
  • Ensure CRO and consultant deliverables and activities are prepared or conducted on time and of high quality. 
  • Prepare planning, strategy, summary documents, etc. for use in communicating with product developers.
  • Ensure compliance with GCP, GMP, and regulatory guidelines.
  • Identify short and long-term project needs, formulate plans for satisfying those needs, and identifying resources to implement project plans.
  • Conduct internal (i.e., within RTI) and external business-development activities to raise the profile of Global Health Technologies’ drug development capabilities.  These activities will include the preparation of proposals for submission to funding agencies. 

Minimum Qualifications:
  • Master's degree in a scientific or technical discipline with 3+ years' experience in biopharmaceutical drug development or clinical affairs; OR a Bachelors’ degree with 5+ years' experience in biopharmaceutical drug development or clinical affairs.
  • Experience with FDA interactions and/or other regulatory authorities.
  • Experience with clinical trials, maintaining essential documents, reviewing/writing protocols, and clinical study reports.
  • Excellent oral and written communications skills.
  • Ability to work as a member of multiple project teams and achieve consensus in diverse groups.
  • Ability to prioritize and multi-task concurrent project demands.
  • To qualify, applicants must be authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status.

Preferred Qualifications:

  • RAC certification a plus. 

#LI-KV1


Physical and mental demands of this role include those that must be met by an employee to successfully perform the essential functions of this job, as outlined above.  Examples include:  remaining in a stationary position for long periods of time; operating a computer and other office machinery; thinking, learning, and concentrating effectively and frequently communicating with other people, both within RTI and outside of RTI; frequently moving about inside and travel between offices and laboratories; frequently conducting laboratory site inspections (if applicable), ability to handle the stress associated in meeting frequent, multiple and tight deadlines, ability to work in excess of 40 hours per week as workload and deadlines may require, consistent demonstration of mental stability and ability to have regular, reliable and predictable attendance.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job, per RTI procedure 4.2.1. 


RTI International is an independent, nonprofit research institute dedicated to improving the human condition. Clients rely on us to answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across the social and laboratory sciences, engineering, and international development. We believe in the promise of science, and we are inspired every day to deliver on that promise for the good of people, communities, and businesses around the world. For more information, visit www.rti.org.
 
For USA Job Postings Only: RTI participates in the US Government E-Verify program. Further information regarding the E-Verify program and laws that are designed to protect you against discrimination relating to your legal right to work in the US can be found here.
 
For San Francisco, CA USA Job Postings Only: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Further information is available here.
 
We are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. Further information is available here.

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