Chief Regulatory Affairs Officer

The Company

OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies.

OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements.

We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow.

Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603.

The Role: We are looking for a Chief Regulatory Affairs Officer to join to the Ocyon Bio Senior Leadership team. This role is responsible for the strategy and start-up efforts, overseeing all regulatory requirements, ensuring that all processes and practices are established, implemented, and maintained in compliance with established requirements.

Major Duties and responsibilities:

• Oversee compliance within their organization, and ensure full compliance with laws, regulatory requirements, policies, and procedures
• Ensure that the company has a deep commitment to providing up-to-date knowledge of regulatory compliance throughout the organization by providing ongoing training
• Be the first and last voice on all regulatory matters, providing clear strategic direction for senior leadership
• Develop, monitor, and update an annual compliance plan that addresses the specifics of the company’s activities and products
• Consistently stay ahead of regulatory and legislative changes that impact the organization and its relationship with regulators
• Be a partner in the development of product marketing concepts and approve relevant packaging and advertising
• Lead compliance teams and monitor the success of staff and programs
• Monitor internal audits and compliance reviews, investigating matters as needed
• Provide the board of directors with detailed compliance reports and inform them about important issues and material violations
• Act as most senior contact for regulators and ensure audits, reviews, and examinations are consistent and accurate
• Foster an environment that encourages employees at all levels to report issues, improprieties, and concerns that could harm the public and undermine the company

Requirement:

• Bachelor’s Degree in sciences Field and/or Master’s Degree in Sciences.
• Fifteen (15) years of working experience in highly regulated industry (pharmaceutical and/or Biopharmaceutical) with at least Ten (10) years of direct experience within Regulatory Affairs or in CMC regulatory or role with CMC regulatory submission responsibilities.
• Experience with global regulatory aspects of CMC across multiple dosage forms involving undefined frameworks with technical complexity and broad scope.
• Experience with process development, analytical characterization, process scale-up and/or regulatory registration of drug substances or drug products (including parenteral dosage forms) is required.
• Advanced interpersonal written and oral communication skills, as well as advanced collaborative skills with an ability to work both reactively and proactively in a timely manner in a dynamic fast-paced environment
• Ability to manage complex projects by exercising independent decision making and analytical thinking skills
• Knowledge/experience of US and/or international regulations, guidelines and regulatory processes for NCEs, NBEs and product life cycle maintenance
• Ability to work in cross-functional and international environment; detail- and goal-oriented, quality conscientious, and customer-focused
• Ability to write and speak English fluently
• Demonstrated track record for successful Health Authority interactions related to CMC submissions.
• Excellent communication skills, both written and oral.
• Proven leadership and motivation skills
• Able to communicate with customers at all levels and capable of managing their expectations

What we offer:

• Competitive salary (DOE).
• Health, dental, and vision benefits.
• Professional development opportunities.
• Opportunity to participate in the company stocks options program.

Working conditions:

Physical Requirements

OFFICE POSITION - While performing the duties of this job the employee is required to:

• Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment
• Specific vision abilities required by this job include close vision requirements due to computer work
• Light to moderate lifting is required
• Moderate noise (i.e. business office with computers, phones, and printers, light traffic).
• Ability to sit at a computer terminal for an extended period of time Sedentary work Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.

Note: This Corporate function may work on a hybrid flexible work solution of 80% of the time on site and 20% of the time remote, subject to changes at any time based on business needs.

We Are An Equal Opportunity Employer

Ocyonbio 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.