Director, Regulatory Affairs

Veristat; Northern (KY); Hybrid; USD 195,000 - 223,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat is seeking a Director of Regulatory Affairs to provide strategic regulatory advice from early development through NDA/BLA. Role involves independent preparation of US IND, NDA/BLA modules, and interactions with FDA and health authorities.

Strong leadership in cross-functional teams and client-facing engagements are required. The role offers remote work options within a global team with extensive project experience in oncology and rare diseases, and a commitment to diversity and

Qualifications

• Bachelor’s degree in science, toxicology, pharmacology, engineering or related field.
• Advanced scientific degree such as Master’s, Ph.D. or Pharm.D. preferred.

Responsibilities

• 10 years of relevant CRO/pharma experience; lead regulatory development projects.
• Thorough knowledge of ICH GCP guidelines and regulatory rules.
• Excellent written and oral communication skills; regulatory documentation preparation.

Skills

Communication skills

Regulatory strategy

Leadership

Cross-functional collaboration

Education

Bachelor’s degree in science

Advanced science degree (MS/PhD/PharmD)

Tools

Microsoft Word

Microsoft Excel

Job description

Director, Regulatory Affairs

Director RA will be client facing and will be responsible amongst others for: Strategic Advice to clients, with focus on early development through to NDA/ BLA. Independent preparation of regulatory documentation such as US IND, NDA/BLA modules, ODD, Fast track / other designations, FDA advice requests. Scientific Interaction with internal cross functional teams Client facing & Agency point of contact: Interaction with clients and FDA, lead interactions with Health Authorities Internal BD & marketing facing role.

Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.

105+ approved therapies for marketing applications prepared by Veristat 480+ oncology projects in the past 5 years 350+ rare disease projects delivered in the past 5 years

Flexible, inclusive culture — 70% remote workforce, 66% women-led teams

What we offer

The estimated hiring range for this role is $195K-223K plus applicable bonus. This hiring range is specific to the US and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data.

Benefits

• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans

What we look for

Bachelor’s degree in science, toxicology, pharmacology, engineering or related field; Advanced Scientific degree such as Master’s degree, Ph.D. or Pharm.D. preferred, with applied training relevant to clinical trials.

10 years of relevant experience working directly for a CRO/ Pharmaceutical Company, with a minimum 5 years of experience leading regulatory development projects.

Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.

Excellent written and oral communication skills including grammatical and technical writing skills, and familiarity with moderately complex study designs and regulatory requirements that apply to Phase I-IV clinical trials are required.

In-depth knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies.

Demonstrated ability to lead by example with demonstrated skill for technical and supervisory leadership of staff.

Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications.

Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.

Equal Opportunity Employer

Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Veristat is proud to provide exceptional services to our clients, assisting in the successful development of innovations that improve and save lives.

We are equally proud to recruit, develop and retain the best and the brightest talent across a variety of business functions to make that happen.

We are an Equal Opportunity Employer that values the strength and creativity that diversity brings to our workplace.

Veristat provides equal employment opportunities to all employees and applicants for employment without regard to age, disability, genetics, gender identity or expression, gender reassignment (i.e., transgender status), marriage and civil partnership, pregnancy and maternity, race (including color, nationality, and ethnic or national origins), religion or belief, sex or sexual orientation, physical appearance, veteran status, source of income, arrest or conviction record or any other category protected under characteristics considered unlawful in any circumstances of employment offers and practices.

Reasonable Accommodations

Veristat is dedicated to providing an accessible and inclusive application experience for all candidates. If you require a reasonable accommodation to complete your application, participate in an assessment, or attend an interview, please contact our Talent Acquisition team at [e-mail] or [phone]. We will work with you to meet your needs, ensuring a fair process. All requests in relation to your application will be treated confidentially.

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