Director, Regulatory Affairs

2 weeks ago

Cary, United States Heron Therapeutics, Inc. Full time

Heron Therapeutics develops cutting-edge medicine to meet unmet patient needs and solve big problems by applying our innovative science and technologies with well-known pharmacology. With therapeutic areas in Oncology and Acute Care, our goal is to offer alternatives so patients can be opioid-free post-surgery. With additional products and indications on their way, we are excited to be growing and adding to our amazing team.

Our entrepreneurial culture gives everyone the chance to be heard with easy access to decision-makers like other smaller companies, along with some of the sophistication and benefits of larger organizations. We developed the Heron Ways of Working to implement training and practices that breathe life into our values and embed them into our daily experience such as open collaboration across teams, self-responsibility & accountability, communication strategies & techniques, and the mindset of always assuming positive intent

The Director, Regulatory Affairs is responsible for global regulatory affairs strategy and management of assigned projects covering the development, registration and post approval phases, and acts as liaison with the health authorities including the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) review divisions and Office of Prescription Drug Promotion (OPDP), European Medicines Agency (EMA), and other regulatory authorities as appropriate. Works closely with other functional areas to develop regulatory strategies and timelines, including regulatory operations, development, pharmacovigilance, legal, marketing, sales operations, and medical affairs.

ESSENTIAL DUTIES & RESPONSIBILITIES

  • Prepare submissions to IND/CTA and marketing applications to the US FDA and other regulatory authorities.
  • Partner with cross-functional areas to plan and review all regulatory submissions and actively manage timelines.
  • Actively participate on product strategy teams and provide advice and direction including identifying and assessing regulatory risks regarding regulatory requirements and
  • Develop and execute effective proactive regulatory strategies and
  • Ability to assess whether technical arguments are presented clearly and conclusions are supported by data and their associated risk assessments.
  • Support U.S. post-marketing activities for commercial products, including review and approval of commercial labeling and advertising/promotional
  • Provide interpretive analyses of regulatory guidance documents, regulations, or directives that impact the Company's development and commercial programs. Advise personnel in other departments regarding their applicability and
  • Perform regulatory intelligence activities to keep current on the regulatory environment and competitive products; communicate such environment to the
  • Review documents and work closely with Regulatory Operations to publish final regulatory submissions to FDA CDER review divisions, OPDP, EMA, and other regulatory authorities.
  • Primary contact for assigned projects with key personnel in FDA CDER review divisions, OPDP, EMA, and other regulatory authorities for assigned
  • Develop proposed product labeling working with Marketing, CMC, Clinical Development, Nonclinical Development and Pharmaceutical
  • Plan, coordinate and lead meetings with regulatory authorities (e.g., Pre-IND, End of Phase 2, Pre-NDA, Scientific Advice and national advice) including meeting requests, meeting background documents and action plan following such
  • Participate in the development of Regulatory Affairs department
  • Establish standards for compliance of regulatory submissions with health authority laws, regulations and guidance
  • Maintain knowledge of the laws, regulations and guidelines governing drug development and
  • Manage and review safety reports and
  • Initiate change controls and conduct regulatory assessments, reviews, and approvals of labeling and manufacturing changes as appropriate.
  • Ensure registration of clinical trials and posting of results to registries such as ClinicalTrials.gov and EudraCT is completed per health authority requirements.
  • Ensure that Heron's applicable products are entered in the Global Unique Device Identification Database.

REQUIREMENTS

  • Bachelor's and/or Master's degree in scientific, health care or related field or equivalent.
  • A minimum of 10 years of pharmaceutical industry experience, with 5+ years of regulatory experience.
  • Experience in preparation of IND/CTA and NDA/MAA submissions and electronic Common Technical Document eCTD preparation.
  • Experience with injectable drug products, aseptic manufacturing processes and medical devices is preferred.
  • Previous management experience is preferred. Must demonstrate the ability to work through others.
  • Must demonstrate understanding of drug development and knowledge of FDA requirements and working knowledge of scientific principles.
  • Direct experience with OPDP and marketed products preferred.
  • Direct experience with FDA required and international experience preferred.
  • A leadership role on project teams with approximately 40% of time in meetings.
  • Highly organized with attention to detail. Strong verbal and written communication skills are required, as well as excellent scientific writing, presentation and documentation skills.
  • Has familiarity with MS Word, MS Excel, Adobe Acrobat and PowerPoint applications. Working knowledge of electronic publishing/file management system.
  • Moderate travel (up to 10-20%).

The above description is intended to describe the general nature of the job that may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position.

Heron is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity.

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