Regulatory Affairs Project Manager

Position Title: Regulatory Project Manager

Position Summary:

AltaThera Pharmaceuticals, a company using innovative science to improve patient care, seeks a Regulatory Project Manager to manage regulatory projects in support of current AltaThera product(s) and future new AltaThera products.

The Regulatory Project Manager will work with AltaThera Team Members, external regulatory experts and consultants, and other entities as needed to develop, define, and manage regulatory submissions and related AltaThera activities in support of product development and evergreening for AltaThera products.

The successful candidate is self-motivated, highly organized, possesses problem-solving skills, creativity, and emotional intelligence.

Key Skills:

• Regulatory submission experience, especially with 505(b)(2).
• Excellent communication skills and ability to work with remote team members.
• High level of organizational skills and attention to detail.

Key Responsibilities:

• Define regulatory project scope, objectives, and deliverables.
• Develop detailed project plans and timelines.
• Manage budgets and track expenses.
• Liaise closely with external consultants to monitor project progress and address risks.
• Support development of regulatory strategies to maintain/evergreen current AltaThera product(s) and support evaluation and development of new products.
• Create and/or manage the creation, review, and filing of regulatory submissions in agreement with defined project objectives (INDs, NDAs, amendments and supplements).
• Maintain regulatory files.
• Schedule and attend meetings for internal and external teams. Prepare agendas and meeting minutes.
• Provide project updates to AltaThera team members and stakeholders with a high level of focus on identifying and managing changes to project scope, timeline and budget.
• Ensure projects are completed on time and meet defined objectives and deliverables.
• Interface with external entities (vendors, institutions, hospitals, etc.) as needed to access information/data and accomplish AltaThera goals and objectives.

What AltaThera Offers

THE OPPORTUNITY TO MAKE A REAL DIFFERENCE!

AltaThera is a precision medicine company using innovative science to improve patient care and solve serious and costly problems. This is a unique opportunity to be a true core member of a well-positioned pharmaceutical company with high growth objectives. The Company has a start-up culture with potential for significant career growth for motivated individuals.

Characteristics & Individual Qualities

Are you a Rock Star with tactical and strategic capabilities who

• Is able to see the big picture but ready to jump right in and get your hands dirty?
• Is energized by setting aggressive deadlines and doing all it takes to meet them?
• Has a curious mind and loves the idea of a start-up where you can be involved in all facets of the business?
• Is ready to leave the politics and bureaucracy of a big company behind?
• Is obsessive about driving fact-based data-driven decisions?
• Is compelled to find an opportunity to do something really significant?
• Has an insatiable drive for constant growth and improvement?
• Thrives on challenges and overcoming setbacks creatively?
• Is candid, transparent and speaks your mind in a way co-workers understand and appreciate?
• Is excited to work within AltaThera’s cultural foundation by living our 5 Core Values:
• Humble
• Hungry
• Adaptable
• People Smart
• Intellectually Curious

AltaThera promotes and supports individual differences and diversity of thoughts and opinions. As an equal opportunity employer, AltaThera is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws.