Director, Administrative And Regulatory Affairs

Job Summary:

We are seeking a dynamic and detailed-oriented Director, Administrative and Regulatory Affairs to join our growing startup company. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passion in improving medication safety for all.

The Director, Administrative and Regulatory Affairs plans, directs, coordinates, and oversees administrative and regulatory affairs activities to meet current and future needs of the organization. The Director, Administrative and Regulatory Affairs is responsible for the successful execution of research and strategic initiatives that demonstrate clinical decision support system safety and efficacy. A hybrid role, the Director, Administrative and Regulatory Affairs ensures that research and operations are conducted in full compliance with applicable regulatory requirements.

Duties/Responsibilities:

Administrative Affairs

• Ensures that departmental decisions and project plans such as those for staffing, development, organization, material efficiency, hardware acquisitions, and facilities are in line with the organization’s business plan and vision.
• Collaborates with executive leadership to develop and meet company goals while supplying expertise and guidance on operations projects and systems.
• Identifies, recommends, and implements new processes, technologies, and systems to improve and streamline organizational processes and use of resources and materials.
• Establishes, communicates, and implements operations-related policies, practices, standards, and security measures to ensure effective and consistent support and execution.

Regulatory Affairs

• Establishes and evolves SOPs, Quality Management Systems (QMS), policies, and procedures to assure research, internal files, and clinical study files conform to Good Clinical Practice regulations and standards.
• Obtain necessary approvals from regulatory agencies and bodies, and tracks and manages all proposal/reporting deadlines, submissions, and status updates.
• Lead the development of regulatory affairs and evidence strategies to best position GalenusRx for successful regulatory approvals and product commercialization.
• Define a strategy to obtain clinical evidence that supports registration of new and expanded products and expansion into new markets.
• Maintains knowledge of all applicable international regulation and regulatory guidance, as well as in-depth product knowledge and clinical / medical knowledge.
• Collaborate with team members to achieve clinical affairs objectives and regulatory compliance/approvals inside and outside of the U.S.
• Responsible for obtaining and maintaining regulatory approvals and compliance in accordance with strategic objectives and in compliance with policies, procedures, standards, and regulations.

Required Skills/Abilities:

• Strong interpersonal and organizational skills.
• Proficient with Microsoft Office Suite or similar software.
• Excellent analytical and problem-solving skills.
• Experience with administrative laws, regulations, standards, and guidance for people management.
• Excellent written and verbal communication skills.
• Proven ability to work independently and be self-motivated.
• Knowledge of clinical pharmacology, pharmacokinetics, and pharmacogenomics is a plus.
• Research studies.
• Well organized with the ability to multi-task and manage complexity.
• Experience with the laws, regulations, standards, and guidance governing the conduct of clinical

Education and Experience:

• Master’s degree in Biotechnology, Biomedical of Life Sciences, Health Sciences, Health Services Administration, Business Administration, or other industry-related field required; PhD preferred.
• At least four years of experience in pharmacy, pharmaceutical biotechnology, or related healthcare experience.
• At least five years in leadership and management required.
• An equivalent combination of education, training and experience that presents the required knowledge, skills, and abilities will be considered.

Physical Requirements:

• Must be able to lift 15 pounds.
• Prolonged periods of sitting at a desk and working on a computer.

Working Conditions:

Remote. GalenusRx reserves the right to change this work arrangement at any time. GalenusRx will not provide moving expenses or fund renovations or decorations for home offices.

Reports to:

• GalenusRx, Presidentand COO

Supervisory Responsibilities:

There is the potential for this position to supervise a full-time Research Assistant, Administrator, Executive Assistant, or equivalent position, dependent on the needs of GalenusRx.

Salary Range:

$90,00-100,000. You will be eligible for a great benefits and rewards package.

Benefits:

GalenusRx is committed to the well-being of our team members and offers a variety of benefits supporting our employees. Salaried/Full-time employees working 35+ hours per week are eligible for our benefits package. Benefits include but are not limited to health insurance, vision, dental, 401(K) Plan, PTO (15 days), Holidays (10), Floating holidays (2).

Disclaimer:

This job description is not intended, nor should it be construed to be an exhaustive list of all responsibilities, skills, efforts or working conditions associated with the job. It is intended to indicate the general nature and level of work being performed by employees assigned to this classification.

GalenusRx is proud to be an equal opportunity employer. GalenusRx will not discriminate against any employee or applicant on the basis of age, color, disability, gender political opinion, religion or belief, nationality, ethnic or social origin, sexual orientation, veteran status, physical appearance, or any classification protected by federal state, or local law. We are committed to creating a diverse and inclusive environment that supports, inspires, and respects all individuals.

To apply*, please apply immediately by sending your CV to [email protected]

Questions regarding this position should be directed to

Veronique Michaud, President GalenusRx, [email protected]

*Closing date: May 26, 2023, 5PM (EST).