Title: Manager Regulatory Affairs

Job Summary

Providing regulatory support during the development of products and the supervision, preparation, and critical review for Frontida Biopharm.

Responsibilities

  • Responsible for ANDA filings to the Agency (also including Controlled Correspondence, Meeting Requests, Responses to Agency questions and other submissions as needed).
  • The Manager evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as required.
  • The incumbent, with minimal guidance, evaluates key documentation and helps to resolve issues.
  • He/she represents Regulatory Affairs on project teams and serves as team leader for projects.
  • The Manager will help to establish regulatory strategies for submissions and manage document deliverables to ensure submission targets/KPIs are met while adhering to appropriate statues, regulations and guidelines.
  • The incumbent will attend calls with sites, some third party, supporting the US market and will work closely with the EVP/BD of Regulatory Affairs to provide Regulatory advice, direction and oversight.
  • The Manager will be help to take the lead on intra/inter departmental/cross-functional initiatives and continuous improvement initiatives.
  • Manages quality control over the entire submission lifecycle, including all component tracking, workflow execution and issue resolution.
  • Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.
  • Evaluates changes to regulatory documents for Frontida Biopharm.
  • Other duties, as assigned, or as business needs require.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  Requirements are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • M.Sc./ BS degree in a scientific discipline.
  • Minimum 5+ years Regulatory Affairs experience required coupled with at least 3 years’ experience in Pharmaceutical industry.
  • Previous Managerial experience preferred. Exhibits strong knowledge of current regulations and guidance’s related to the filing, approval process, and maintenance of NDAs,  ANDAs. And 505(b)(2)
  • Demonstrates a basic understanding of pharmaceutical drug development.
  • Ability to manage timelines within a project team environment.
  • Ability to work independently, without supervision, and in teams.
  • Ability to effectively liaise with FDA, various disciplines within Frontida Biopharm and third parties.
  • Ability to establish and maintain good working relationships.
  • Demonstrates good negotiation and management skills.
  • Excellent verbal and written communication skills.
  • Must be well organized, detail oriented, have the ability to multi-task and manage changing priorities.

Knowledge and Skills

LANGUAGE SKILLS:

Ability to read/write and comprehend complex instructions, correspondence and memos. Ability to effectively present information in a one-on-one or group situation, plus across all levels and functions of the organization, government agencies and general public.

MATHEMATICAL SKILLS:

Ability to understand analytical, formulation, and bioequivalence studies test data, business forecasts/plans, and budget information.

REASONING ABILITY:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to sit. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the assorted duties of this job, the employee works in a lab/office environment.

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