Manager/Sr. Manager, Regulatory Affairs Operations

The Manager/Senior Manager of Regulatory Affairs Operations is responsible for managing regulatory submissions, including project management and cross-functional reporting.

ESSENTIAL RESPONSIBILITIES:

• Plan and develop content and project timelines for routine submissions(protocols, information amendments, clinical study reports, etc.)
• Maintains and tracks regulatory submission documentation (hard copy or electronic), including regulatory authority correspondence
• Track regulatory commitments and timelines for maintenance activities (e.g., Annual Reports).
• Ensuring that documents are formatted in accordance with appropriate style guides
• Source document formatting, internal hyperlinking, and bookmarks, including resolving technical issues with formatting.
• Troubleshoot eCTD software issues (xml backbone)
• Provide operational support in all aspects of eCTD and non-eCTD publishing
• Managing third party publishing vendors to ensure submission timelines are met
• Acts as a liaison with external, third-party organizations to provide regulatory support for the completion of outsourced regulatory submissions.
• In-depth knowledge of CFR (Title 21) and International Conference on Harmonisation (ICH) guidelines including thorough knowledge of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) policies and procedures.
• Understanding of the Quality Assurance (QA) function as it applies to regulatory documents including the ability to review and QC documents intended for regulatory submissions.
• Recommend and implement innovative process ideas to impact Regulatory Affairs operations, including Standard Operating Procedures (SOP’s), and policies.
• Represent the company with a high level of integrity and professionalism.
• Adhere to the company’s policies and support management decisions and goals in a positive, professional manner.
• Performs other tasks and projects as assigned.

QUALIFICATIONS AND EDUCATION:         

• Bachelor’s degree in a life sciences discipline is required and 5+ years’ progressive experience managing regulatory submissions and archives.
• Hands-on experience in the process of generating, reviewing, and formatting documentation for worldwide regulatory submissions
• Experience across a product lifecycle (i.e. from development to post-marketing).
• Comprehensive knowledge of drug development process, biopharmaceutical technology, IND Submissions.
• Project Management Experience.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Able to recognize need(s), find solutions, take the initiative, and address issues proactively.
• Extensive software skills, including the use of Microsoft Office and Adobe Professional.
• Proficiency with ISI Toolbox (or similar).
• Proficiency with StartingPoint Templates and Toolbar (or similar).
• Demonstrated ability to work efficiently under conditions of multiple deadlines and changing priorities to produce a large volume of high-quality material with meticulous attention to detail.
• Excellent time-management, organizational, problem-prevention and problem-solving skills.
• Excellent verbal and written communication skills.
• Ability to treat confidential information with discretion and make ethical and sound business decisions on situations that may involve sensitive matters.
• Pragmatic and strategic thinker who meets objectives and leads by example.
• Focused approach with consideration of project timelines.
• Results-oriented with a dedication to quality and reliability in all work tasks.

ABOUT ACHIEVE LIFE SCIENCES
At Achieve, we are committed to bringing medicines forward that contribute to a healthier world. Achieve is a specialty pharmaceutical company committed to advancing cytisinicline as a widely available treatment option to help people battling nicotine addiction.

If you enjoy working in a dynamic team environment and are passionate about making a difference, we invite you to apply. Achieve is an equal opportunity employer poised for growth. We strive to attract, develop, and retain highly qualified individuals representing the diverse communities we serve.

To apply, please send your resume and cover letter to [email protected]