19/03/2023, 22:31 (1) Regulatory Manager/Senior Regulatory Manager - Cell and Gene Therapy | Precision For Medicine | LinkedIn

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Regulatory Manager/Senior Regulatory Manager - Cell and Gene Therapy

Precision For Medicine Brussels, Brussels Region, Belgium (Remote) 1 week ago 7 applicants

Full-time · Mid-Senior level

1,001-5,000 employees · Biotechnology Research

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About the job

Regulatory Manager/Senior Regulatory Manager – Cell and Gene Therapy

Precision for Medicine (CRO) are recruiting a Regulatory Manager/Senior Regulatory Manager to join our team, candidates can be based in the following countries: UK,
Spain, France, Italy, Netherlands, Belgium, Germany, Hungary, Slovakia, Serbia, Romania or Poland.

Position Summary

The Regulatory Manager (RM)/Senior Regulatory Manager (SRM) provides regulatory strategy and development guidance for optimal conduct of clinical trials,
regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory
submissions in compliance with applicable regulations. The RM/SRM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or
Ethics Committees, as applicable. The RM/SRM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as
supporting and enhancing Precision for Medicines corporate Regulatory function.

Essential functions of the job include but are not limited to:

Provides regulatory guidance throughout the clinical development life cycle

Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific
advice/regulatory authority meetings, orphan designations, paediatric planning, and marketing applications. Also provides strategic regulatory input as required
Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory
standards
Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
Works within a project team, and where necessary, leads project for the region or globally
Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership
updated.
Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure
the highest quality of submitted information
Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
Provides ICH GCP guidance, advice and training to internal and external clients
Serve as representative of Global Regulatory Affairs at business development meetings

Qualifications

Minimum Required:

Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline

Computer literacy (MS Office/ Office 365)
Fluent in English

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19/03/2023, 22:31 (1) Regulatory Manager/Senior Regulatory Manager - Cell and Gene Therapy | Precision For Medicine | LinkedIn
Preferred

Graduate, postgraduate
Possesses basic understanding of financial management

Other Required

At least 5+ years or more relevant regulatory affairs experience working for a Clinical Research Organisation, Biotech or Pharmaceutical company and have at
least 3+ years experience leading Clinical Submissions
Must have Cell and Gene therapy experience, with extensive knowledge of EU GMO approval procedures
Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones and specialized knowledge of regulatory activities for at
least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice
Procedures, and post-approval submissions
Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied
Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
Availability for domestic and international travel including overnight stays

Competencies

Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research
activities
Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture
and positive interactions with customers and teammates
Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment
Motivates other members of the project team to meet timelines and project goals
Flexible attitude with respect to work assignments, and new learning
Resolves project related problems and prioritize workload to meet deadlines with little support from management
Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
Collects data of consistently high standard
Communicates effectively in the English language both verbally and in written form
Conducts formal presentations to a wide variety of audiences including colleagues, investigative

staff, and clients with a high level of proficiency

Any data provided as a part of this application will be stored in accordance with our Privacy Policy .

Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender
identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable
to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at
QuestionForHR@precisionmedicinegrp.com .

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About the company

Precision For Medicine

Following
61,791 followers

Biotechnology • 1,001-5,000 employees • 1,223 on LinkedIn

Precision is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new
therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. This maximizes
our clients’ insight into patient biology, delivering more predictable trial outcomes and accelerating clinical development. We apply our expertise to trials at…allshow
stages…
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19/03/2023, 22:31 (1) Regulatory Manager/Senior Regulatory Manager - Cell and Gene Therapy | Precision For Medicine | LinkedIn

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