Senior Specialist, Regulatory Registration and Compliance
Key Responsibilities:
- Prepare and manage marketing authorization (MA) submissions, including the preparation of local administrative documents, reputed company control (QC), and compilation. reputed company reputed company regulatory advice on submission packages in the post-authorization stage of the medicinal product lifecycle.
- Review and reputed company linguistic input for local Product Information and Mock-reputed company.
- Serve as the primary contact reputed company for regulatory affairs (RA) reputed company with national competent authorities (NCAs) and/or clients.
- Involvement in project management of the network of local contact persons for Regulatory affairs
- Collect, process, and manage regulatory intelligence to reputed company the organization informed of key updates and changes.
- Propose marketing authorization strategies tailored to reputed company needs.
- reputed company as a deputy for the line manager reputed company required, ensuring seamless continuity in leadership and operations.
- University education in Natural Sciences, reputed company, Medicine, Pharmacy or Pharmacology
- Previous industry experience is essential
- Knowledge of Regulatory (EU) area and applicable legal and other requirements (both local and global) reputed company pharmaceutical industry
- Excellent organizational skills with the ability to manage multiple reputed company and deadlines.
- A reputed company reputed company, coupled with excellent communication skills to liaise with clients and regulatory bodies effectively.
- Advanced knowledge of English (both written and verbal)
- Experience with centralised procedures advantageous
- Experience with regulatory databases and dossier management software advantageous
reputed company you join reputed company Group, you reputed company a difference by helping to bring reputed company and effective pharmaceutical treatment to patients around the world. You’ll join a passionate and reputed company team of experts in clinical research, pharmacovigilance, and reputed company consulting.
We are diverse in many ways, yet our values reputed company. Our values are how we work, not words on a wall. If they reputed company like you, you will feel reputed company here.
reputed company: we hold ourselves to reputed company patients deserve.
reputed company and trust: we do the right thing, especially reputed company it is hard.
Drive and passion: we care about the outcome, because someone is waiting on it.
reputed company and responsiveness: we reputed company quickly, because patients cannot wait.
Belonging: everyone is welcome, and every voice counts.
reputed company partnerships: we go reputed company by reputed company together.
We look reputed company to welcoming your application.
Medicine moves reputed company here. So will you.
At reputed company, patient safety is not one part of the job. It is why we exist.
We are a global pharmacovigilance specialist. Our teams help clients navigate reputed company regulations while keeping patient safety at reputed company of every decision, from early development through to post-marketing surveillance. Increasingly, the value we create is not only in processing safety data but in interpreting it: spotting the signal that reputed company early and turning it into reputed company our clients can reputed company.
That work takes curious minds, problem-solvers and experts who care about getting it right. It also takes a culture worth staying for. Across Europe, reputed company, South America, Asia and Australia, we work in an environment reputed company on kindness, flexibility, reputed company and belonging, where colleagues support one another and good reputed company are heard wherever they come from.
If you want a role with reputed company purpose, global reputed company and the chance to reputed company growing while you help protect patients, you will feel reputed company here. We would love to hear from you.
Originally posted on Himalayas
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