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Manager, Regulatory Affairs - Olympia, United States - Perspective Therapeutics
Description
ObjectiveReporting directly to the VP, Global Regulatory Affairs, the Manager, Regulatory Affairs will
key part in guiding and executing regulatory strategies to advance our innovative radiopharmaceutical products through development and towards commercialization.
Responsibilities include defining and or authoring compliant content for new and existing dossiers, implementing and managing tracking systems, and preparation of electronic submissions.
S/he will directly participate in project teams in support of key projects, regulatory deliverables, prioritization, strategy, providing guidance, and tracking regulatory process.
Essential FunctionsCollaborate with cross-functional teams to develop the content and manage regulatory submissions for clinical-stage radiopharmaceutical products.
Facilitate the preparation, review, and submission of regulatory documents to health authorities, including INDs, CTAs, BLAs, and marketing applications, in compliance with applicable regulations and guidelines.
Manage regulatory publishing activities, maintenance of document management system for regulatory affairs, archive the eCTD submissions and maintain submission logs.
Stay abreast of evolving regulatory requirements, guidelines, and industry trends related to radiopharmaceuticals and cancer therapies, and provide strategic guidance to internal stakeholders.
Provide guidance for regulatory aspects of clinical trials, including protocol development, regulatory submissions, and interactions with regulatory agencies and ethics committees.
Collaborate with internal teams to ensure regulatory compliance throughout all stages of product development, including preclinical, clinical, and in the future, commercialization phases.
Identify risk and make risk-based decisions to facilitate solutions for process and submission.Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Educations / Experience
Bachelor's degree in life sciences, pharmacy, or related field; advanced degree preferred.
5-7 years of experience in regulatory affairs within pharmaceutical or biotechnology industry.
Focus on radiopharmaceuticals and oncology products preferred.
Proven track record of successful regulatory submissions, including INDs, CTAs, and marketing applications, for clinical-stage products.
Experience interacting with health authorities, particularly the FDA, EMA, and other global regulatory agencies, in the oncology therapeutic area.
Knowledge / Skill / Ability
Strong understanding of regulatory requirements and guidelines related to radiopharmaceuticals, cancer therapies, and clinical development processes.
Familiarity with drug development,
compliance,
product commercialization and life cycle management processes.
Excellent oral and written communications skills.
Entrepreneurial, innovative, energetic, hands-on,
and
team oriented.
Ability to build cross-functional relationships and work collaboratively.
Ability to think strategically and execute.
Flexibility and comfort level with ambiguity in a small company environment.
Ability to travel for business as required.
Travel up to 20% is required.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
Duties, responsibilities, and activities may change at any time with or without notice.For information on Perspective Therapeutics, visit our website at:
.
Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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Were you referred to Perspective Therapeutics by a current employee? If yes, please provide their name below:
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