Regulatory Operations Associate II

Job Overview:

Responsible for creation/revision/compilation/approval of Specifications/Documents for submission by Fortrea clients to US, EU, Japan, and ROW health authorities and oversight of the same, as applicable.

Summary of Responsibilities:

• To ensure that all necessary supporting data of permissions /approvals are in place for the product intended to import, or manufacture, test and analysis or export to meet the current applicable regulatory requirements.

• Compilation of the application according to the check list issued by Health Authority. Managing the office copies and filling to ensure easy retrieval.
• Maintenance and creation of monthly report basis on the license submission, and receipt of final approval and tracking of licenses for timely follow ups.
• Proper management of granted Licenses/NOC, Form 11 or Form 29, Form 25 etc.& work proactively with users for ensuring filing and retrieval compliance.
• FDA Application data feeding of existing and new licenses in the electronic system of FDA, CDSCO and NCB/CBN for ensuring timely submissions. Updating user information in the system such as licenses, other relevant data and CTS on day to day basis.
• Align with individual license user department for creating documentary based on the latest regulatory requirement with applicable process.
• Maintenance of standard data base of the licenses and permission available in the site.
• Maintain training related documentation as per Fortrea and client requirements.
• Support with onboarding, training and mentoring new associates.
• Other duties as assigned by management.

Qualifications (Minimum Required):

• Bachelors or Masters in Pharmaceutical Science with minimum1 – 3 Years of Industrial experiencein regulatory affairs particularly in thearea of Indian regulatory environment withlicensing as a primaryfocus
• Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream or Packaging Postgraduate/Diploma/Certification in Packaging as applicable. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”
• Speaking-English and/or other languages as applicable.

Experience (Minimum Required):

• Knowledge of various licenserequirements as per D&C act and rules thereof
• Basic knowledge of license application formats as per the regulatory requirements
• Competent enough to handle regulatory queries regarding license applications
• Well versed with thepharmaceutical development and manufacturing aspects
• Well versed with new guidance’s for obtaining test license, import license, manufacturing license, export  NOC etc.
• Is aware of the various forms at different stages of product life cycle‐ from development till export.
• Added advantage would be knowledge of licensing process for NDA/ NCE’s.
• Ability to work with different teams
• Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable.
• Interpersonal skills, Proactive, Taking ownership, Precise, Goal oriented.
• Good organizational and time management ability.
• Good analytical capabilities and Customer focus.
• Good review skills and concern for quality.

Preferred Qualifications Include:

• Bachelor’s in Pharmacy or related science degree (or equivalent); OR Advanced Degree (e.g., PhD or Masters) with 1-5 years of relevant experience. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR
• Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream or Packaging Postgraduate/Diploma/Certification with minimum 2-5 years of experience in packaging field will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.”
• Knowledge of Management Information System (MIS) and electronic data management system (e.g: Regulatory Information Management, etc.) system will be preferred.
• Diploma or certification in Regulatory Affairs will be preferred.

Physical Demands/Work Environment:

• Physical demands: Available to travel as per business requirement.
• Work environment: Office environment or remote.

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