Regulatory Affairs Associate III
DivIHN Integration Inc
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists Navjot | 630 847 1023 and Priya | (630) 847 1830
Job Title: Regulatory Affairs Associate III
Duration: 12 months
On site or remote role? I would say given the Covid situation, it would currently be hybrid depending on the individuals preference.
What are the top three to five technical skill requirements for your role? See attached
What are your top three to five soft skill wants for the role? Collaborative, Attention to Detail, Flexible/Adaptable, Strong Communication and Work ethic
Essential Duties and Responsibilities
This role resides within the Regulatory Operations- RA Systems and Submissions Operations organization.
Drive integration and transition of products into regulatory operation processes.
Project team member representing Regulatory Affairs Operations, driving timelines and deliverables related to submission documents.
Primary Regulatory Operations liaison to internal and external groups, including regulatory authorities on electronic submissions and documentation systems.
Regularly interacts with RA management and functional peer groups inside and outside the department.
Interacts internally and externally to influence policy and strategy.
Provide system and process support, development and training.
Understanding and knowledge of the format and content of regulatory submissions and/or registration documents and associated registration processes
Hands on experience with electronic submissions and eCTD (INDs, BLAs. NDAs)
Expert skills in electronic publishing/document/data management systems (e.g. Documentum, ISI Toolbox, eCTD Xpress and database creation/management)
Sound basis of Regulatory knowledge
Ability to manage complex projects and timelines in a matrix team environment
Strong oral and written communication and presentation skills
Demonstrated interpersonal skills including strong negotiation skills
Education and/or Experience.
Bachelor's Degree or country equivalent with a minimum of 2-3 years in a regulated environment
DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
Scientific Knowledge, eCTD, regulated environment, electronic submissionsApply