Job Description

Job Description

Job Description

Description:

REPORTS TO

Chief Operating Officer

JOB DESCRIPTION/SUMMARY

The Senior Manager, Regulatory Affairs will manage, evaluate, and complete regulatory projects consistent with company goals. This position is responsible for primary authorship and supporting CMC regulatory activities, preparing regulatory submissions and ensuring compliance with global regulatory requirements maintaining the electronic trial master files, reviewing, and overseeing the production of clinical and regulatory documents in support of product development applications.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The main Regulatory Affairs responsibilities of this role include but are not limited to the following:

• Serves as the regulatory lead on CMC development teams, providing guidance and oversight.
• Manages administrative aspects of global regulatory submissions and life cycle management, ensuring that submissions are in support of company goals, of the highest quality, and delivered on-time.
• Represents Regulatory in cross-functional teams and provide guidance to teams on the regulatory requirements and risk(s) to support clinical development programs including preparation and maintenance of e.g., IND, CTA, and IMPD filings.
• Develops, reviews and/or files INDs, CTAs, briefing documents and maintenance of development and approved applications including authoring and managing the development of DSURs, annual reports, CSRs, Protocols, Investigator Brochures, and amendments as needed.
• Provides regulatory representation and expertise on cross-functional teams as needed. Collaboratively develop global regulatory strategies to support CMC, nonclinical, and clinical activities across various development programs.
• Conducts regulatory research and analysis, develop and communicate recommendations regarding new/emerging regulations to management and project teams.
• Collaborates with and supervises contributions from contractors and vendors.
• Develops and manages project timelines for regulatory submissions.
• Manages and maintains the electronic trial master files for regulatory, clinical, and non-clinical departments.
• Other duties as needed.

EDUCATION AND EXPERIENCE REQUIREMENTS

• Bachelor's degree in scientific discipline with at least 5 years of experience in CMC Regulatory Affairs.
• Proven success in preparing and submitting CMC sections of INDs, CTAs, NDAs, and MAAs
• Deep understanding of global regulatory frameworks and evolving guidelines
• Ability to lead in a fast-paced, collaborative environment with shifting priorities
• Strategic mindset with a hands-on approach to problem-solving and execution
• Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical) including experience with CTD/eCTD.
• Working knowledge of GMP, GLP, and GCP regulations as well as an understanding of the pharmaceutical product life cycle.
• Working knowledge of FDA and ICH regulatory guidance and regulations.
• Working knowledge of ex-US regulatory affairs (EMA, MHRA, PMDA) desirable

KNOWLEDGE AND SKILLS REQUIREMENTS

• High degree of proficiency Microsoft Office Suite (i.e., Word, PowerPoint, etc.), Outlook Internet applications, WebEx, Zoom
• High attention to detail and excellent proofreading and editing skills
• Strong analytical, interpersonal, and well-developed problem-solving skills with the ability to work in a positive and collaborative fashion
• Ability to multi-task, professional demeanor, strong attention to detail
• Self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive attitude
• Must be dependable; someone willing to go the extra-mile to get things done
• Team player with excellent oral, written and verbal communication skills.

VIKING THERAPEUTICS

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA

Notice to Agency and Search Firm Representatives

Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

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