Regulatory Affairs Specialist

We are seeking a Regulatory Affairs Specialist to provides regulatory support to all preapproval and post approval activities for new products and existing products through product’s lifecycle. Prepares and compiles drug product regulatory documents. Provides regulatory guidance to matters related to product development. Primary Functions: Coordinates activities in the preparation of Regulatory Drug Product Applications (i. e. ANDA, NDAs, Marketing Authorizations, Amendments, Annual Reports, Supplements, CMC Sections, etc. ): a. Searches, retrieves and compiles all the necessary documentation for authoring of the applicable regulatory filingb. Ensures technical accuracy and regulatory completeness of documentation to support drug product regulatory submissions.

c. Provides regulatory guidance to the chemistry, manufacturing and control sections of IND, NDA, ANDA; and supplemental filings, in line with previous development work. Provides regulatory support and direction to all matters related to process development, new product, and technology transfer by: Reviewing technical information and reports in support of new products for accuracy and regulatory acceptability Advising clinical supply manufacturing and packaging activities Coordinate shipping of clinical samples for bioequivalence studies Monitoring the conduct and progress of clinical investigations Review and approval of technical documents such as specifications, protocols and reports Coordinates and oversees product post-approval activities:

Searches, retrieves and compiles all the necessary documentation for authoring of the applicable post approval filing Advises on CMC activities in support of post approval changes for new and existing products Evaluates change requests for regulatory acceptability to maintain drug approval conditions Coordinates and performs Drug Product Listing activities for new and revised productsSecondary functions:

Performs labeling activities; reviews and approves promotional materialDevelops and maintains the department’s Standard Operating Procedures, and related documents, as they apply to Regulatory Affairs missionEvaluates new tendencies and changes in regulations related to pharmaceutical products and give support to the operational areasReceives, reads, interprets and determines applicability of FDA or International regulations to development of products, submissions and post-marketing reportsSupport regulatory audits requirementsEvaluate applicable laws and regulations to determine impact on organizational activitiesActs as an advisor on regulatory matters and explain regulations, policies, or proceduresPerforms other duties as assigned. Minimun Requierements: Bachelors degree, preferably in Science:

Pharmacy, Chemistry or Biology. Equivalent experience related to regulatory affairs or in the pharmaceutical industry may substitute for academic background in science. Minimum of three to five years of broad-based Quality Operations, pharmaceutical manufacturing and/or related regulatory experience Experience with regulatory impact assessment of changes and registration requirements on global markets, compiling information and preparing regulatory filing documentsExperience with the preparation and review of dossier for regulatory filing is highly desirableKnowledge of regulatory filing requirements for US, EU and ROW. Knowledge of applicable State, Federal and International Regulatory requirements (DSPR, OSHA, EPA, FDA, ASSMCA, MHRA, ANVISA, MOH, etc. ).

Knowledge in Quality Control SystemsExcellent communication skills in English and SpanishOther Requirements: Computer knowledge in Words, Excel, and Power Point programsDocument management and project management desirableTravel may be required"Drug Free Workplace Policy: In accordance with our commitment to maintaining a safe and productive work environment, all applicants for employment with our company are required to affirm their commitment to a drug-free workplace and consent to pre-employment drug testing as a condition of employment.

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