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Senior Specialist, Regulatory Affairs

Company: Aktiv Pharma Group
Location: Broomfield
Posted on: May 3, 2021

Job Description:

Aktiv Pharma Group is hiring for a Senior Specialist, Regulatory Affairs. We are a fast-growing company focused on addressing unmet medical needs through a proprietary drug delivery system. The Regulatory Affairs, Senior Specialist will help develop the strategic direction and execute the tactical operational aspects of global regulatory compliance and submissions for drug-device combination products that include novel drug-delivery systems. This position will be responsible for developing and tracking the regulatory plan from pre-IND/IDE through pivotal clinical trials which may include 505(b)(2) submission types, to commercialization through NDA/PMA/510K.  This position will execute all applicable regulatory submissions and communications and develop strong relationships and obtain regulatory approvals from the FDA and other global regulatory agencies.

At Aktiv Pharma Group, we value the diversity of perspectives and backgrounds our employees bring. We are committed to achieving a diverse workforce through application of our equal opportunity employment policy and by providing a work environment free of discrimination and harassment. We work according to our values of truth, caring, goodness and perseverance, and encourage individuals with the required skillsets and these values to apply.

Essential Duties/Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

  • Develop and implement a regulatory strategy and execute related regulatory activities needed to achieve regulatory agency approval of combination products.
  • Develop and implement strategies in collaboration with other internal departments to ensure development and manufacturing activities are sufficient to meet regulatory submission and approval expectations.
  • Serve as a liaison between regulatory agencies and operating divisions of the company to respond to requests for information from regulatory agencies.
  • Prepare and submit applications, annual reports and documents for the FDA and other regulatory agencies.
  • Develop responses to questions or deficiency letters from regulatory agencies.
  • Coordinate with the various internal departments regarding device design and drug development, as applicable, to ensure compliance with regulatory submission requirements.
  • Actively support the regulatory submission process, including acting as a point of contact for FDA or other regulatory agencies.
  • Provide internal guidance to ensure regulatory compliance of combination products with the FDA and other applicable regulatory jurisdictions, identifying and assessing regulatory risks.
  • Maintain current knowledge of regulations, applicable to Aktiv Pharma Group
  • Monitor regulatory affairs and the effect changes will have on company operations and products.
  • Coordinate with the various internal departments regarding device design and drug development, as applicable, to ensure compliance with regulatory submission requirements.
  • Ability to establish proficiency in emergency auto-injector regulatory requirements.
  • Develop and maintain professional relationship in federal, state, and local regulatory agencies.
  • Maintain regular and punctual attendance.
  • Perform other additional duties, responsibilities and tasks as directed.

Job Qualifications

Competencies, Knowledge, Skills, and Abilities:

  • Extensive knowledge/background of applicable government regulations
  • Demonstrated experience with all levels of regulatory submissions IDE/IND, PMA, 510(k), NDA, etc. with knowledge of international regulatory processes preferred.
  • Experience working directly with the FDA preferred (with other regulatory agencies optional)
  • Experience working in the FDA 505(b)(2) pathway preferred.
  • Ability to inform and educate personnel on regulations and policies that impact companys products and operations.
  • Excellent strategic planning, analytical and problem-solving skills required; in addition to a continued desire to provide tactical execution at all levels.
  • Proven leadership skills, along with problem solving ability and creativity.
  • Positive, self-motivated, detailed oriented.
  • Effective oral and written communication skills to communicate in both formal and informal settings.
  • Ability to work independently and well within a team.
  • Proficient with applicable database and compliance software.
  • Proficient with Microsoft Office Suite or similar software.

Education or Formal Training:

  • Bachelors degree or higher in a technical or clinical discipline (engineering, biology/ life science)

Experience:

  • A minimum of eight (8) years of experience in regulatory experience in the medical device/pharmaceutical/ combination product industry.
  • An equivalent combination of education and experience may be substituted for this requirement.

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Keywords: Aktiv Pharma Group, Broomfield , Senior Specialist, Regulatory Affairs, Other , Broomfield, Colorado

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