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Associate Director / Director, Regulatory Strategy - Regulatory Lead
Reporting to the Head of Regulatory Affairs, the candidate will act as Regulatory Lead for our cardiac or neurological gene therapy programs work closely with cross-functional teams and development partners while managing relationships and interactions with external strategic and technical regulatory service providers in accordance with health authority and ICH requirements. We are seeking a motivated and ambitious individual to provide leadership and support to regulatory activities to achieve our strategic vision. In addition to being a key member of our project teams, she/he will provide organizational support as the company and its product development pipeline grow.
LocationWe are a NYC based company and our work culture is a hybrid model with days in the office and days working from home; we welcome applications from top talent located across the Northeast.
Job Responsibilities- Contribute to the development and implementation of regulatory strategies to facilitate the progress for assigned programs in all phases of development.
- Serve as the Regulatory Affairs representative on assigned project teams and assure the progress of projects by providing direction, solutions and feedback to the teams in support of regulatory submissions.
- Actively participate in interactions with regulatory agencies for assigned programs.
- Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while planning for global BLAs / MAAs.
- Interact with Regulatory Affairs personnel within external service providers and development partner companies.
- Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals.
- Perform other duties as required
- Bachelors or advanced degree in a scientific discipline, with a minimum of 4 years’ experience working in a regulated environment, at least 4 years of regulatory experience in the biopharmaceutical industry
- Experience a plus and experience with rare disease/ orphan drug development and gene therapy desirable.
- Direct experience with pharmaceutical regulatory submissions, managing major regulatory filing(s) such as IND/CTA or NDA/BLA/MAA.
- Extensive knowledge of FDA regulations and practices and ICH guidance as well as strong knowledge of global health authority regulations and practices.
- Demonstrated leadership and success in management of regulatory activities and interacting with regulatory agencies, including the FDA.
- Excellent verbal and written communication skills.
- Collaborative, analytical and interpretative skills that enable review and compilation of reports and other documents used in regulatory planning and submissions.
- Ability to work with minimal supervision, to set priorities to meet timelines, to motivate and influence others; prior management experience is a plus.
- Previous experience in successfully leading assigned activities within cross-functional teams.
LEXEO Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.
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Average Salary For an Associate Director
Based on recent jobs postings on Zippia, the average salary in the U.S. for an Associate Director is $128,258 per year or $62 per hour. The highest paying Associate Director jobs have a salary over $188,000 per year while the lowest paying Associate Director jobs pay $87,000 per year
5 Common Career Paths For an Associate Director
Vice President
Vice presidents are usually considered the second-in-command in the organization, depending on the organization structure. They take over when the president is unavailable to fulfill duties. They may also represent the organization in external events and other official functions. They are important members of the boardroom, and their opinions are usually sought after as well. Vice presidents are usually poised to follow the president's footsteps in the organization, especially if the president is nearing retirement. They also make urgent and crucial decisions when the president is not available to do so. Vice presidents must have strong business acumen, decision-making skills, and professionalism.
Director
Directors work in show business, whether in a film, a television show, or a theatre production. They are responsible for bringing the material to life. They work with the writers to get a clear vision of how the production should look. They lead the production team in planning for the production, identifying filming or rehearsing schedules, casting for roles, and other aspects that need to be decided upon. Directors provide direction to the actors to ensure that the actors understand their role and will be able to effectively convey emotions to the audience. They also manage all other crew members and communicate their expectations clearly so that everyone on the set is working towards one vision.
Operations Director
Operations directors oversee all company operations. They have the power to set the direction, change the course of the organization, and reform strategies to ensure efficiency in how the company operates. Operations directors manage business operations effectively by constantly analyzing company data and by anticipating any challenge that may come their way. As such, they make sound business decisions and recommendations that will help strengthen the organization. Operations directors oversee finances, quality control, and even human resources. They ensure that all aspects of the business are considered in making business operations decisions.
Regional Director
The primary role of regional directors is to oversee and provide guidance to the managers that report to them. They coordinate with employees to discuss business progress and create strategies to accomplish the company's goals. It is their responsibility to oversee the recruitment and training of staff and implement a marketing strategy to maximize sales and profitability. It is also their responsibility to identify and address staff performance issues and collaborate with department teams on market growth opportunities.
Program Director
Program directors are employees who oversee all aspects of a specific program in the company. They usually work in nonprofit organizations or are assigned to a department doing corporate social responsibility activities. Program directors ensure that the program is in line with the company's goals. They also ensure that the resources assigned to the program are properly managed and that all finances are accounted for. They create strategies to ensure the success of the program and communicate these to everyone involved. They lead the implementation and evaluation of the program.
Illustrated Career Paths For an Associate Director
Associate Director Jobs FAQs
What is associate director level?
The associate director level is the midpoint between management and the executive team. This level is an upper management position that acts as a liaison between management and the executive team.
An associate director is a person in charge of planning or organizing day-to-day duties within their company area. They are tasked with implementing strategic plans that have been communicated to them by the executive team.
The primary duties of an associate director include overseeing related business development, maintaining relevant client information, managing day-to-day work, and looking after the critical deadlines related to projects and assignments of the company.
A significant portion of their role is taking strategic communications from the executive level, translating them into operations strategies, and delegating that to the lower management level to be implemented.
What is the difference between a director and an associate director?
The difference between a director and an associate director is that a director is higher than an associate director. An assistant director typically works directly under a director in a more active management role.
A director of a company oversees the performance of entire departments. They usually focus on completing high-level tasks and working closely with the executive team to make big-picture decisions or offer solutions to complex challenges impacting the whole department or company.
Meanwhile, the associate director handles the daily responsibilities and tasks to ensure that their department runs smoothly. Directors typically set and communicate goals to associate directors, who must create strategies for their team to achieve these goals successfully.
Associate directors will manage department members by delegating tasks, offering guidance and support on complicated projects, and conducting performance reviews to discuss each employee's strengths and improvement areas.
They will then report to the director for approval on strategies or project implementations, critical company information, and feedback on the team's or their performance.