Regulatory Affairs Consultant Labelling - German Speaker

Posted Yesterday
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2 Locations
In-Office or Remote
Mid level
Pharmaceutical
The Role
The Regulatory Affairs Consultant will manage the labeling lifecycle, ensure compliance with regulations, prepare documents for submissions, and support labeling initiatives in a global team.
Summary Generated by Built In

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.

We are seeking an experienced Regulatory Affairs Consultant specializing in global labelling operations to join our growing Regulatory Affairs team. This role offers the opportunity to shape labelling strategy across multiple markets and drive global alignment of product information for pharmaceutical portfolio of our clients.

The role can be fully home based or office based.

Key Responsibilities:
  • Manage end-to-end labeling lifecycle including preliminary assessment, implementation, and post-approval maintenance

  • Provide innovation and technical expertise for the creation, maintenance, and implementation of labeling to meet country-specific regulatory requirements

  • Execute labeling operations globally with precision and efficiency

  • Participate in a 'follow the sun' model to ensure timely execution of labelling activities across time zones

  • Prepare and review labelling documents for regulatory submissions and variations

  • Maintain labeling databases and tracking systems

  • Support global labelling harmonization initiatives

  • Collaborate with regional regulatory teams to ensure compliance with local requirements

  • Monitor regulatory intelligence related to labelling requirements

Skills and Experienced required for the role:

  • University degree in a life science discipline

  • A few years of experience in the biotech/pharmaceutical industry

  • Labelling/regulatory experience with global responsibilities

  • Experience with CCDS development and maintenance

  • Strong understanding of regulatory labelling requirements across multiple markets

  • Direct experience working with Swissmedic

  • Excellent attention to detail and organizational skills

  • Experience leading teams in a matrix organization is expected

  • Ability to work effectively in a global, virtual team environment

  • Fluent in German and English, written and spoken

Skills Required

  • University degree in a life science discipline
  • A few years of experience in the biotech/pharmaceutical industry
  • Labelling/regulatory experience with global responsibilities
  • Experience with CCDS development and maintenance
  • Strong understanding of regulatory labelling requirements across multiple markets
  • Direct experience working with Swissmedic
  • Excellent attention to detail and organizational skills
  • Experience leading teams in a matrix organization is expected
  • Ability to work effectively in a global, virtual team environment
  • Fluent in German and English, written and spoken

Parexel Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.

  • Healthcare Strength Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
  • Retirement Support Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
  • Leave & Time Off Breadth Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.

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The Company
HQ: Durham, North Carolina
20,524 Employees

What We Do

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.

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