Associate Regulatory Affairs Specialist-Madison

Primary Objectives of the Position:
 
Under general supervision, from the Regulatory Affairs Manager, helps prepare and maintain submissions to regulatory agencies and required compliance reports, such as Drug Master Files (DMF’s) and Annual Updates an amendments to the DMF’s in compliance with ICH Q7A and 21 CFR 314.
 
Duties and Responsibilities:
 

1. Assists in the preparation of new, and helps maintain, existing Drug Master Files (DMF’s) for US FDA and Certificates of Suitability for the European Community (EC) in Electronic Common Technical Document (ECTD) format.
2. Keeps current with the changing EC Drug Substance or Active Pharmaceutical Ingredient (API) registration requirements.  Keeps current with the changing FDA cGMP requirements, Code of Federal Regulations application to the DMF’S, IND’s and NDA’s and USDA importation and exportation requirements.
3. Prepares document packages for clients in support of DMF, IND and NDA filings.
4. Collects, reviews interprets and summarizes annual QC data deviations/discrepancies change control records, procedure history files, and other appropriate documentation pertinent to the generation of Annual Update in accordance with company procedures.
5. Reviews USP/NF Pharmacopoeial Forum Supplements and alerts QC/QA to proposed and upcoming changes in the compendia (e.g. BP, EP, AOAC) and assures compliance with such revisions in a manner similar to USP/NF updates.  Assures appropriate follow up activities are carried out in a timely fashion to ensure analytical methods, labeling, product descriptions / specifications, raw material chemical descriptions specifications are updated within the required time frame.
6. Serves as alternate for the Regulatory Affairs Manager to the Change Control Committee.
7. Participates in facility cGMP audits (customer driven and regulatory agencies).
8. Other duties projects as assigned.  Ability to work longer hours and some weekends, as needed.

 
 
 
 
 
 
 
Job Standards:
 

1. Education:  Bachelors Degree in a Life Sciences field such as chemistry, biology and microbiology.
2. Experience:  Minimum of 2 years previous experience in a cGMP pharmaceutical, and laboratory, manufacturing site is required.  Regulatory Affairs experience, including ECTD experience, is preferred.
3. Standards:  Demonstrated ability to handle confidential material, detail oriented.  Demonstrated proficiency in math, written and oral communication skills.  Excellent interpersonal skills.  Intermediate level working knowledge of Microsoft Word, Microsoft Excel, Microsoft Access and Windows environment.  A basic understanding of chemistry laboratory tests operation and / or activities. Duties involve the use of judgment and initiative and a general knowledge of the purpose and function of Standard Operating procedures (SOP’s), DMF’S, IND’s, NDA’s, and ANDA’s.  Accurate typing skills (40 WPM), and proof reading skills.  Good attendance is required.
4. Work Environment:  Work area is typical of an office environment.
5. Physical Standards:  Job requires standing, sitting, walking, reaching, bending, twisting and squatting.  Use of hand(s) for fine manipulation and simple grasping is required.  Fine manipulation and frequent lifting of 1-20 pounds is required.  Excellent vision, speech, and hearing are required.

 
Call John Stewart at Argus 608 442-6487. E-mail resumes to Johns@argus-tech.com

John Stewart
Argus Technical Services
1310 Mendota St Suite 103
Madison, WI 53714
(608) 442-6487 (Main)
(608) 441-9987 (Fax)
Johns@argus-tech.com