- Clinical Site Activation Coordinator
- Senior Director, Talent Acquisition
- Biostatistician/Senior Biostatistician
- Benefits Manager
- Bioinformatics and Computational Scientist
- Medical Editor
- Senior Manager, Regulatory Affairs
- Medical Director/Senior Medical Director, Pharmacovigilance
- Accounts Payable Coordinator
- Senior Director Clinical Pharmacology
- Statistical Programmer
- Medical Writer
- Contracts Manager
- Lead Clinical Data Manager
- Clinical Supply Chain Manager
The Karyopharm Workplace
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.
Position: Senior Manager Regulatory Affairs
Responsible for acting as regulatory project manager of US and EU regulatory submissions including INDs, IMPD/CTAs and NDA/MAAs including creating and maintaining regulatory trackers and timelines, management updates, scheduling team meetings, creating agenda, meeting minutes and conducting follow-up on action items with team members. The Senior Manager will act as the regulatory lead on clinical projects, contributing to the development and implementation of regulatory strategy, provide regulatory guidance on protocol design, IVD development, and serving as the regulatory contact with relevant regulatory authorities, including managing queries, meeting requests, responses, as appropriate.
- Responsible for regulatory project management of US and EU regulatory submissions including but not limited to IND/IMPD/CTA, NDA/MAA submissions, agency meeting briefing books and meeting minutes, orphan drug applications, special protocol agreement, fast track and breakthrough designation requests, PRIME submissions, orphan drug application, agency query sponsor responses.
- Create and maintain regulatory submissions tracker and timelines, scheduling team meetings, agenda, meeting materials, minutes and follow-up with team members on action items.
- Act as regulatory lead on clinical projects, responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs. Contribute to the development and implementation of clinical, pre-clinical and cmc regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).
- Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
- Manage regulatory team members including assigning and prioritizing work while providing oversight and guidance to the team members
- Identify and assess regulatory risks for assigned projects or programs.
- Prepare and deliver effective presentations for external and internal audiences.
- Contact regulatory agencies relevant to assigned projects or programs, as appropriate.
- Participate and contribute in Health Authority meetings.
- Represent regulatory on relevant project teams.
- Mentor other Regulatory staff members.
- PhD or MS degree required, Life/Health Sciences preferred.
- Minimum 8+ years pharmaceutical industry experience, 5 years regulatory experience.
- Strong project management skills including familiarity with PM toolkits.
- Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
- Demonstrate excellent written and oral communication skills.
- Ability to represent the department in project teams.
- Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports 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.
- Computer literate.
- Sensitivity for a multicultural/multinational environment.
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