The Regulatory Affairs Associate, with some guidance prepares, reviews and submits high quality, regulatory submissions such as ANDAs to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws.
With some guidance compile and complete the ANDAs with high-quality, following the regulatory guidelines and internal processes within time lines.
Coordinates with external vendors for project support activities. This may include but not limited to RS statements, TSE/BSE statements, Melamine free certificates, cGMP certificates, Debarment certificates, US agent letters, DMF LoAs, Technical data sheets, and technical drawings, Quantitative compositions of colors, flavors e.t.c.
Organize and maintain submission components associated with a regulatory submission electronically. This may include scanning, converting to pdf, bookmarking, hyper linking, electronic processing and uploading in e-CTD Xpress e.t.c under superior guidance.
Screen the ANDAs against ANDA checklist to avoid screening queries.
Track the committed timeliness and follow up with the internal departments proactively for required documents.
Prepare and update the road map for each assigned product with committed timeliness by each department.
Follow up with purchase team for DMFs and compliance to DMF review comments. Additional Responsibilities
Work with colleagues in resolving regulatory issues and/or problems
Should archive and maintain all submissions in a systematic way.
Performs administrative functions as directed by Management to support projects and to ensure the smooth operation of the department.
Maintain current knowledge of regulations and other issues that affect products and industry
Maintain the regulatory databases up to date and as per the set criteria’s.
The above statements are intended to describe the general nature and level of the work being performed by employees assigned to this position. This is not intended as an exhaustive list of all responsibilities, duties, and skills required. Aquestive reserves the right to make changes to the job description whenever necessary.
As part of Aquestive’s employment process, final candidate will be required to complete a drug test and background check prior to employment commencing. Aquestive is an equal opportunity employer. All qualified applicants will be considered without regard to race, national origin, gender, age, disability, sexual orientation, veteran status, or marital status.
Bachelors Degree (BA/BS) Scientific or related field
0 to 2 years Regulatory Affairs or related coursework Skills
Regulatory Affairs Certification (RAC) optimal
Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required. - Intermediate
Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects. - Intermediate
Excellent written and verbal communication skills and interpersonal skills. - Intermediate
Ability to communicate effectively and collaboratively as part of a team in a respectful manner - Intermediate
Ability to interface with professionals domestically and abroad. - Intermediate
Ability to work independently, self-starter - Intermediate
Good problem solving skills and analytical ability - Intermediate
Strong computer skills in order to learn new programs as quickly as possible. Experience in MS Word, Excel, Outlook and Adobe Acrobat is a must. - Advanced