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Regulatory Affairs Associate

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Experience:

Senior (5-10 years)

Work from:

Offer summary

Bachelor's Degree in scientific field, 3-5 years regulatory experience, Strong working knowledge of drug regulations, Fluent in English.

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

Responsibilities :

Independently reviews and compiles ANDAs, Amendments, Supplements,
Annual Reports, etc. for FDA submissions in eCTD format as per FDA
regulations and guidelines.
Reviews Labeling Change Control requests and approve revised labeling.
documents, which may include physician and patient package inserts as well as various types of container labels.
Interacts effectively with functional business units to obtain.
documentation required for submissions.
Evaluates, reviews, and processes change controls to communicate regulatory submission strategies and acquire necessary and compliant documentation.
Frequent interaction with Regulatory Agencies.
Maintains compliance with regulatory requirements for generic drugs for the US market.
Maintains Regulatory Databases.
Identifies potential issues and resolves routine problems.
Prioritizes workload. Receives little supervision for most assignments.
Receives general instructions for non-standard analyses and projects.
Interfaces to negotiate and exchange information with all levels of management.
Performs other duties as assigned.
Adheres to all applicable procedures, cGMp, company policies and any other quality or regulatory requirements. (For example: OSHA, DEA, FDA, EMEA, ANVISA, etc.)

Requirement:

Bachelor's Degree in a scientific related field, preferred, with 3-5 yrs. regulatory experience.
Associate degree is accepted with minimum 5 years regulatory experience.
Computer knowledge, problem-solving skills, strong working knowledge of regulatory and drug development processes, strong technical knowledge, strong communication skills, innovative and creative, possess good judgment and leadership ability.
Fluent in written and spoken English. Good oral and written communication skills are required.
Adherence to all health, safety & environmental requirements in support of departmental and site HSE goals. Work in a safe and efficient manner