Director, Regulatory Affairs

Veristat; Valencia; A distancia; EUR 80.000 - 100.000; Jornada completa

Descripción de la vacante

A global healthcare consultancy is seeking a Director of Regulatory Affairs to manage regulatory projects and provide strategic support. You will lead cross-functional teams and ensure compliance with regulatory guidelines. The ideal candidate has 8-10 years of experience and a relevant advanced degree. This role offers a flexible work culture with opportunities for professional growth.

Servicios

Flexible time off

Paid holidays

Medical insurance

Formación

• 8-10 years of experience in CRO/Pharmaceutical industry.
• Thorough knowledge of ICH GCP guidelines.
• Demonstrated ability to lead and mentor staff.

Responsabilidades

• Lead and manage regulatory and cross-functional projects.
• Provide strategic support in regulatory decision-making.
• Act as a mentor and project supervisor for junior members.

Conocimientos

Excellent written and oral communication skills

Knowledge of ICH guidelines

Interpersonal and organizational skills

Technical writing skills

Leadership skills

Educación

Bachelor’s degree in science or engineering

Advanced Scientific degree (Master’s, Ph.D., Pharm.D.)

Descripción del empleo

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Director, Regulatory Affairs

The Director, Regulatory Affairs leads and manages assigned regulatory and cross-functional projects; provides strategic and operational support to Veristat clients in regulatory decision-making processes, filings and maintenance of healthcare products, translating regulatory requirements into practical applications to ensure the success of clinical trials and regulatory submissions. S / he will serve on Veristat multidisciplinary project teams, provide independent regulatory strategy advice, advice on regulatory agency interactions, manage agency communications, lead the preparation of submissions, and create strong rapport with clients. The Director Regulatory Affairs acts as a point of escalation for challenging regulatory issues and serves as a mentor and project supervisor to more junior team members.

Job Description

Director, Regulatory Affairs

The Director, Regulatory Affairs leads and manages assigned regulatory and cross-functional projects; provides strategic and operational support to Veristat clients in regulatory decision-making processes, filings and maintenance of healthcare products, translating regulatory requirements into practical applications to ensure the success of clinical trials and regulatory submissions. S / he will serve on Veristat multidisciplinary project teams, provide independent regulatory strategy advice, advice on regulatory agency interactions, manage agency communications, lead the preparation of submissions, and create strong rapport with clients. The Director Regulatory Affairs acts as a point of escalation for challenging regulatory issues and serves as a mentor and project supervisor to more junior team members.

The Director Regulatory Affairs will oversee the Regulatory aspects of projects and project teams through the management of internal staff and through interaction with Executive-level staff. They are responsible for the maintenance of optimal department processes, the implementation of project-specific strategies, and the development and implementation of department strategies to increase productivity and quality.

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
• Learn more about our core values here!

What We Offer

Benefits vary by location and may include :

Flexible time off

Paid holidays

Medical insurance

What We Look For

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

8 -10 years of relevant experience in CRO / Pharmaceutical Industry

Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and regulatory guidelines in the relevant territories as well as drug development, clinical trials, and clinical research.

Excellent written and oral communication skills including grammatical / technical writing skills, and familiarity with drug development, agency interactions, study designs and regulatory requirements that apply to clinical trials are required.

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

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

Automated Decision Making : All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.

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

Seniority level

Seniority level

Director

Employment type

Employment type

Full-time

Job function

Job function

Legal

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