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Senior Director, Regulatory Affairs

Company: Karyopharm Therapeutics
Location: Newton
Posted on: June 9, 2021

Job Description:

Responsibilities

The (Senior) Director is responsible for the development and implementation of regulatory strategies for specific projects, while serving as the regulatory lead on the respective program teams. He/she will also be the regulatory contact with relevant regulatory authorities, as appropriate.

Reports to the Vice President, Regulatory Affairs:

  • Accountable for the assigned regulatory portfolio from strategy development and implementation to execution of submissions for all stages of development
  • Responsible for regulatory compliance with pre- and post-approval filings and reporting requirements
  • Develop response and submission strategies to regulatory information requests in close collaboration with cross-functional team members
  • Provide regulatory leadership and guidance to assigned program teams
  • Develop various briefing packages and regulatory applications (e.g. orphan, pediatrics, expedited review pathways, etc.) to the FDA and other global health authorities, as applicable
  • Lead submission teams to successful filing and approval of all types of submission packages
  • Complete documents and other assigned tasks within established timelines and with high quality - in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes
  • Identify and assess regulatory risks for assigned projects or programs
  • Contribute to regulatory intelligence, regulatory science, and regulatory policy
  • Work collaboratively within Regulatory Affairs and cross-functional teams
  • Prepare and deliver effective presentations for external and internal audiences
  • Contact regulatory agencies relevant to assigned projects or programs, as appropriate
  • Participate and contribute to Health Authority meetings
  • Develop and mentor junior Regulatory staff members

Qualifications

  • Minimum B.S. degree in life/health/technical sciences required
  • Postgraduate degree in Regulatory Affairs a plus
  • Minimum 10+ years of regulatory experience or a PhD/PharmD or equivalent with at least 5 years of experience within the biotech or pharmaceutical industry
  • A minimum of 7 years regulatory experience within the drug development and approval process in IND/CTAs/Marketing Applications
  • Knowledge of global regulatory requirements
  • Experience preparing NDAs/MAAs, as well as experience in working within a matrix environment
  • Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals
  • Demonstrate excellent communication skills
  • Ability to represent the department in project teams
  • Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports (where applicable) workload
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
  • Demonstrated effective cross-cultural awareness and capabilities
  • Experience in interfacing with relevant regulatory authorities
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
  • Knowledge and understanding of applicable regulations
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Ability to perform research related to regulatory issues
  • Computer literacy is required
  • Sensitivity for a multicultural/multinational environment

Overview

Karyopharm Therapeutics Inc. (NASDAQ: KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead compound, XPOVIO (selinexor), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. NEXPOVIO (selinexor) has also been granted conditional marketing authorization in combination with dexamethasone for adult patients with heavily pretreated multiple myeloma by the European Commission. In addition to single-agent and combination activity against a variety of human cancers, SINE compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm has several investigational programs in clinical or preclinical development. For more information, please visit www.karyopharm.com.

Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company's Human Resources department.

Keywords: Karyopharm Therapeutics, Newton , Senior Director, Regulatory Affairs, Other , Newton, Massachusetts

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