Regulatory Submissions Specialist at Pharmaceutical Company in Missouri, MO, United States —
- Pharmaceutical Company
- Missouri, MO, United States USA
- 12/16/19 2019-12-16
Job ID: 136131
With guidance and supervision, responsible for utilizing available software and company work instructions to prepare high quality US regulatory submission documents in line with appropriate regulatory requirements, policies, business strategies, processes, and established time-lines.
Prepare submission documents, ensuring all components meet format and technical requirements.
Ensure the completeness and organization of the documents according to the submission plan and as requested by the Submissions Management Manager.
Populate electronic submissions software templates utilizing information gathered from stakeholders and/or regulatory authorities.
Through the use of electronic submissions systems (e.g. Electronic Submissions Gateway), and at the request of the Submissions Management Manager, transmit submission packages to the regulatory authorities.
Monitors and tracks the transmission to the authorities.
Pro-actively identify submission issues to avoid gaps, delays, or non-compliance.
Retrieve correspondence from the authorities and disseminate to the appropriate stakeholder.
Provide technical assistance to colleagues in the utilization of the electronic submissions software, as well as other document creation tools (e.g. Microsoft Word and Adobe Acrobat).
Education: Bachelor's degree and/or two years related industry experience;
Associate's degree and/or 4 years of relevant industry experience or, in lieu of degree, 8 years of relevant industry experience.
Position requires a high level of proficiency with computer skills. Requires competent verbal and written communication skills. Requires the ability to interface with internal customers, international colleagues, and external contacts
This position requires a strong knowledge of computer fundamentals and effective use of standard software, . Must also be a self-starter and demonstrate the ability to function under supervision.
Demonstrated skills in regulatory document preparation, management, technical support, and archiving.
Proficient in electronic submission software (eSubmitter) and associated applications (Microsoft Office, Adobe, and others)
Possesses a deeper technical understanding of related systems in order to address and resolve technical issues as needed.
Strong communication and interpersonal skills are required.
Must be detail-oriented, well organized with good planning, and decision-making skills. Must be able to prioritize assigned activities and effectively accomplish tasks. Must be able to handle multiple priorities and act independently.
Demonstrated ability to develop collaborative partnerships with stakeholders.
Demonstrated knowledge of related processes
Excellent technical skills
Demonstrated ability to manage conflicts and negotiate difficult situations
Demonstrated flexibility and adaptability. Must be able to quickly adapt to and accept a changing environment and be willing to take on any task required to provide support to the US Pharmaceutical Regulatory Affairs Submission Management team.
Demonstrated learning agility. Must be able to learn and use new systems/tools, methodologies and processes, while not jeopardizing quality.