Job ID#: RA-001
Location: Field/NJ/Maryland
Posting Date: July 2020

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Overall Purpose:

The Vice President of Regulatory Affairs (RA) & Quality Assurance (QA) is responsible for directing the AsclepiX’s global regulatory and quality assurance strategies. The VP establishes the organization’s goals and objectives regarding regulatory affairs and quality assurance and ensures they are achieved. This individual is responsible for leading all submissions and communications with regulatory authorities and managing international submissions and responses. Additionally, this individual will drive the activities of the quality assurance program with a view towards phase-appropriate documentation, developing and managing internal training and SOPS, continuous improvement, and implementation of corrective and preventive actions.
In this role, the VP ensures that documentation requirements for products and processes are established through change control and assures ongoing maintenance of the QA System. This individual has the overall responsibility for managing required resources, overseeing a significant budget, and meeting regulatory submission schedule necessary to ensure the effective fulfillment of corporate goals and objectives. He/she will partner with key stakeholders to ensure they are tied into regulatory and quality assurance strategies and execution.

Essential Duties & Responsibilities:

Primary Responsibilities

• Manages the preparation and reviews submissions to the FDA and other global health authorities
• Manages international regulatory submission requirements, including the day-to-day responsibilities of regulatory submissions
• Provides guidance and recommendations to key stakeholders within the organization and monitors compliance with regulatory and quality assurance requirements and commitments
• Coordinates responses and interactions between the company and regulatory agencies on matters relating to AsclepiX’s product regulatory submissions
• Leads the Quality Assurance program to develop and maintain appropriate SOPs for a clinical stage development company, to oversee training of all relevant personnel, and to ensure that quality objectives are being met
• Maintains up-to-date knowledge and understanding of regulatory requirements and concerns that affect the company and communicates changes to relevant personnel
• Organizes and promotes company-wide quality system improvement efforts
• Leads strategies for an effective document control system
• Keeps leadership apprised on the status, objectives, risks, and mitigation plans associated with the various internal projects, as well as ensures regulatory teams are aware of current integrated program timelines
• Remains current with regulatory intelligence and ensures submissions are aligned with current standards/expectations
• Demonstrates expert knowledge of submission or technology-related global Health authority guidelines/regulations
• Act as regulatory contact and strategist with the FDA, international regulatory agencies, and other regulatory bodies.
• Lead, and direct Quality Operations in driving compliance activities related to FDA regulations, and quality systems standards.
• Provide regulatory oversight for product development, manufacturing, and product expiry/retest
• Provide overall review, day-to-day management and operational success for all regulatory functions including the successful integration of activities cross-functionally
• Coordinate the review and approval of product labeling
• Identify issues early in the submission process that could potentially impact product development
• Determine submission requirements and coordinate plans and timelines with Project Management
• Evaluate risks and safety issues and recommend regulatory solutions during the clinical phase
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approvals
• Organize, prepare, and review FDA applications and other regulatory documents, including clinical study protocols/data and CMC
• Monitors regulatory outcomes and provides input and advice to Senior Management Team
• Leads organization through regulatory due diligence
• Keeps ahead of domestic and international regulatory requirements and changes within the regulatory registration processes
• Lead the RA/QA organization to foster best in class in talent and operating practices
• Work in close alignment with R&D, Clinical, manufacturing and compliance functions

Additional Dimensions:

• Must be able to work internally with all levels of the Company as well as externally with Consultants, Vendors and Agents.
• Ensure that RA/QA organization complies with all policies and standards.
• Ensure that all Corporate HR Policies and Programs are effectively implemented and respected by all colleagues in order to attract, retain, and develop talent.
• Champion AsclepiX’s Core Values across the organization and challenges the team to subscribe to them.
• Ensure the RA/QA organization operates to the highest standards of business ethics and quality standards.

Qualification Requirements:

Education & Experience

Minimum Requirements:

• 20+ years’ experience in Pharmaceutical QA and Regulatory Affairs
• Five to ten years’ experience in managing personnel and complex activities. These should include experience in quality management.
• PharmD or PhD preferred; Bachelor’s degree required
• Proven ability in leading and directing regulatory affairs, compliance, and quality assurance activities.
• Ophthalmology/Oncology/Peptide experience is preferred
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
• Excellent communication, analytical and organizational skills
• Ability to provide vision and leadership
• Demonstrated ability to interface and maintain effective relationships with all levels of employees in a team-oriented environment.
• Excellent interpersonal skills.
• Effective communication skills and team participation skills.

Knowledge & Abilities:

• Have a comprehensive and disciplined approach to risk management and regulatory compliance through an intimate understanding of processes and systems, a network of appropriate contacts, and an in-depth knowledge of the internal operations and mentality of the FDA and other health authorities.
• Experience working with global regulatory processes required
• A comprehensive understanding of the industry’s complex legal and regulatory requirements is essential

Physical Demands

Standard physical demands: sitting at desk, working at computer

Work Environment

Standard office environment, multiple floors with stairs.

Travel required.

To perform this job successfully, and individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

AsclepiX Therapeutics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, or any other protected category.

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Job ID#: M-001
Location: New Jersey
Posting Date: December 2020

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Overall Purpose:

The VP of Technical Operations Manufacturing is responsible for leading the development and scale-up of our product portfolio focused on transforming the treatment of ocular diseases. They will manage and oversee our contract service providers for drug substance and drug product process development, analytical development, and manufacturing and testing.

The VP of Manufacturing is responsible for building and delivering critical projects that will have a direct impact on the growth and success of AsclepiX

Essential Duties & Responsibilities:

Primary Responsibilities

• Ensure the quality, robustness, and efficiency of the process and analytical science supporting AsclepiX manufacturing activities
• Overall management and leadership of AsclepiX industrial activities and contractors, including Contract Manufacturing Organizations and Contract Testing Organizations
• Planning and strategy around future manufacturing requirements and milestones to support later development stages, market approval, and commercial supply
• Delivery of investigational drugs of sufficient quality and quantity to meet active clinical program and pipeline requirements
• Ensure contractor operations are highly functional and include the proper organizational structure, capabilities, facilities, and equipment for development, manufacturing, quality control, storage, and shipping and receiving activities, as well as quality assurance and regulatory support
• Lead budget and forecast preparation for CMC activities and establish cost of goods models for current and future manufacturing processes
• Provide CMC guidance and content for regulatory submissions and participate in meetings with global regulatory agencies as needed
• Oversee the request for proposal process and provide technical review and signature of contractor statements of work Presentation of manufacturing strategies and summaries to AsclepiX Board of Directors
• Collaboration with senior management and project teams to advance development plan initiatives and achieve program and portfolio objectives
• Foster a scientific approach to engagement with AXT107

Additional Dimensions:

• Must be able to work internally with all levels and functions of the Company as well as externally with Consultants, Vendors and Agents.
• Ensure that Manufacturing applies with all policies and standards.
• Ensure that all Corporate HR Policies and Programs are effectively implemented and respected by all colleagues in order to attract, retain, and develop talent.
• Champion AsclepiX’s Core Values across the organization and challenges the team to subscribe to them.

Qualification Requirements:

Education & Experience

Minimum Requirements:

• Bachelor’s degree in chemistry, biology, pharmacy, or relevant engineering degree required; MBA preferred with 20+ years of proven experience in Operations Manufacturing within the Biotechnology/Pharmaceutical Industry
• Must have experience managing a Contract Manufacturing Organization and Contract Testing Organization
• Prior experience working on a new drug product launch required
• Must have experience providing CMC guidance and content for regulatory submissions.
• Proven ability in leading and directing
• Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
• Excellent communication, analytical and organizational skills
• Ability to provide vision and leadership
• Demonstrated ability to interface and maintain effective relationships with all levels of employees in a team-oriented environment.
• Excellent interpersonal skills.
• Effective communication skills and team participation skills.

Knowledge & Abilities:

• Experience working with Global Manufacturing processes

Physical Demands

Standard physical demands:

Sitting at desk, working at computer

Work Environment

Standard office environment, multiple floors with stairs.

Travel required.

To perform this job successfully, and individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

AsclepiX Therapeutics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, or any other protected category.

APPLY NOW