Match score not available

Unlock Premium Benefits Today!
🚀 Elevate your career with priority access.
Stand out to top recruiters with Jobgether Priority Access:
  • ✅ Top Match: We help you identify job offers where you're a perfect fit.
  • ✅ Exclusive Referral Service: Connect directly with recruiters as a Jobgether Certified Premium User.
  • ✅ Personalized Feedback: Receive feedback and expert guidance on applications, and have your profile manually reviewed.

Start Your Free Trial Now!

Start my free trial

Senior Regulatory Affairs Manager - CMC (various locations)

extra holidays - extra parental leave - fully flexible
Remote: 
Full Remote
Contract: 
Full time
Experience: 
Expert & Leadership (>10 years)
Work from: 
Hungary, Romania, United Kingdom, Ireland, Italy, Croatia, Serbia

Offer summary

Qualifications:

10+ years of experience in regulatory affairs, Extensive knowledge of CMC writing, In-depth understanding of EU guidelines, Excellent project management skills.

Key responsabilities:

  • Write CMC sections for regulatory submissions
  • Develop and implement variation strategies
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.

We are looking for a Senior Regulatory Affairs Manager/Consultant with 10+ years of experience in regulatory affairs, including CMC expertise. This challenging role offers the opportunity to work on diverse projects, manage client relationships, and contribute to regulatory strategies in a global pharmaceutical environment.

This is a client dedicated project, without people management responsibility. The role can be home or office based in various European locations.

Key Responsibilities:

  • Write CMC sections (23S, 23P, 32S, 32P) and scientific rationales for regulatory submissions and responses

  • Develop and implement variations strategies based on EU guidelines

  • Coordinate CMC activities across multiple projects

  • Liaise with global affiliates and manufacturing sites

  • Provide project leadership and management

  • Ensure client satisfaction and project quality

  • Identify new business opportunities and contribute to proposal preparation

Required Qualifications:

  • 10+ years of experience in regulatory affairs

  • Extensive knowledge of CMC writing and variations strategy

  • In-depth understanding of EU guidelines (Variation, ICH, EMA)

  • Excellent project management and organizational skills

  • Strong communication abilities and client management experience

  • Ability to work independently and as part of a team

  • Proficiency in English; additional languages are a plus

Preferred Qualifications:

  • Experience with regulatory agencies (e.g., FDA, MHRA)

  • Industry-recognized certifications or advanced degrees

  • Publication history or experience presenting at industry conferences

Required profile

Experience

Level of experience: Expert & Leadership (>10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Client ServicesRegulatory CMCRegulatory AffairsProject ManagementRegulatory Affairs

Other Skills

  • Teamwork
  • Organizational Skills
Are you interested?

Regulatory Affairs Manager Related jobs

See more Regulatory Affairs Manager jobs
Sign in or sign up with Google or LinkedIn