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Regulatory Affairs Consultant Safety/Labelling

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Freelance
Experience: 
Mid-level (2-5 years)
Work from: 
Poland

Offer summary

Qualifications:

Minimum of Bachelor's Degree in a Scientific or Technical Discipline, 3-5 years experience in an industry-related environment, Previous experience in the pharmaceutical industry, Experience with regulatory authorities.

Key responsabilities:

  • Acting as expert for labelling-related activities
  • Providing strategic labelling guidance and input
Parexel logo
Parexel XLarge http://www.parexel.com
10001 Employees
About Parexel
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
See more Parexel offers

Job description

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a Regulatory Affairs Consultant - Safety/Labelling to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various European locations.

Key responsibilities will include:

  • Acting as expert for labelling-related activities

  • Providing strategic labelling guidance and/or input in regulatory impact assessment, submission preparation and execution

  • Developing, supporting and reviewing labelling and/or safety-related content

  • Creating and maintaining the CCDS; leading and coordinating CCDS updates, coordinating and overseeing the implementation of updates into local labels

  • Advising on the regulatory requirements for labelling updates in different global regions e.g. EU and ROW.

  • Experienced in managing responses to regulatory authoring questions and negotiating company positions with regulatory authorities

Skills and experience:

  • Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred

  • 3-5 years of experience in an industry-related environment

  • Previous experience working in the pharmaceutical industry in support of Global Labelling or in a Regulatory (Clinical / Safety) role

  • Experience interacting with a regulatory authorities

  • Critical thinking and problem-solving skills

  • Project leadership and management knowledge

  • Excellent interpersonal and intercultural communication skills, both written and verbal

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Regulatory AffairsPatient SafetySpecimen LabelingProject ManagementGovernment Regulation AnalysisContent DevelopmentRegulatory Requirements

Other Skills

  • Problem Solving
  • Non-Verbal Communication
  • Interpersonal Communications
  • Critical Thinking
Are you interested?

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