Junior Associate Regulatory Affairs

Website Aucta Pharmaceuticals

Aucta Pharmaceuticals, Inc. - CMOCRO

Aucta Pharmaceuticals, Inc. is a technology-based company focusing on the development and commercialization of Branded Specialty Products. Aucta is a pharmaceutical company creating better products of proven molecules using 505(b)(2) regulatory pathway. Through innovation, Aucta is creating new therapeutics, including new dosage forms, new dosing regimens and new indications.

Summary

In alignment with organizational goals, Junior Associate, Regulatory Affairs supports the business and development in day-to-day activities associated with Reg CMC, management of clinical trials and the timely compilation and submission of INDs, NDAs, ANDAs, Annual Reports, Periodic Reports, Amendments/Supplements, and Deficiency Letter Responses to the FDA.

Essential Duties and Responsibilities

This position is responsible for various regulatory activities to prepare, review and submit high quality regulatory submissions to the health authorities in accordance with regulatory guidelines, applicable federal laws and standards. Examples include, but are not limited to:

Submission and Product Lifecycle Management

  • Prepares and review CMC submission documents from regulatory perspective to meet scientific and technical requirements for acceptability and approvability by FDA.
  • Author and review technical/regulatory/clinical documentation related to INDs, NDAs, ANDAs, Amendments, Supplements, Annual Reports, Safety Reports and Regulatory authority responses or other applications, as assigned, to support original submissions, amendments, supplements, and annual reports. Prepare electronic files for inclusion in eCTD submissions, per the applicable guidelines.
  • Organize the scientific source documents and regulatory documents to support submissions.
  • Author and review the regulatory components of packaging artwork, label copy, advertising, and

    promotional and educational materials to ensure accuracy and compliance of claims.

  • Support drug regulatory strategies throughout the product development process from drug

    development to post-marketing surveillance.

  • Manage establishment registrations and drug listings including the submission of SPL via

    ESG/CDER Direct

  • Liaise with CROs for the management of clinical trials, including but not limited to, protocol

    review, site management, site initiation, etc.

  • Ensure timely and accurate submissions per business objectives and determine deliverables that

    are aligned with regulatory strategies.

  • Interact with functional groups across the organization in the development of relevant data to

    complete regulatory submissions.

  • Support the development of regulatory processes for pre-approval compliance activities, submission planning and management.
  • Assist in project-related communications with clinical CRO, CMO, regulatory partners, customs, and governmental authorities.
  • Monitor applicable regulatory requirements; assure compliance with internal and external standards and guidance documents.
  • Submission of import/export regulatory documentation.
  • Author and review SOPs.

Qualification and Experience Desired

  • BS in a science (preferably Biology, Chemistry, Pharmacy).
  • Preferably 1 year of pharmaceutical industry experience in regulatory or analytical experience.
  • Proficient in Microsoft Windows environment including, but not limited to, Microsoft Office

    products; Adobe Acrobat and plug-ins; document management systems

  • Ability to learn new technology and apply to business needs.
  • Strong scientific and technical background
  • Strong and proficient communication skills (written and verbal; persuasive technical writing).
  • Must have a working knowledge of US Regulatory Submissions.
  • Has through understanding of cGMP and GLP Practices as well as ICH guidance.
  • Experience in labeling regulations, policies, guidelines; hands-on experience in drug labeling,

    establishment registration, and drug listing preferred.

  • Familiar with regulatory submission publishing and validation; hands-on experience in Adobe Pro,

    Global Submit, Lorenz Validator preferred.

  • Working knowledge of MS Word, Excel, Adobe and other MS Suite applications
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team

    environment consisting of internal and external team members.

  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing

    priorities and deadlines.

  • Excellent planning, organization, and time management skills including the ability to support and

    prioritize multiple projects.

  • Ability to read, analyze, and interpret scientific and technical Agency guidance.

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