Regul Affairs - Large Molecules - Niche Projects

My client is the spin off of a big German pharma company. This spin off has became a very fast growing consultancy company active in more than 100 countries, and the company is characterized by its international and dynamic environment. For his new projects in the field of Regulatory Affairs, my client is currently looking for a Regulatory Affairs Manager (m/w).

Many clients of the company are very well-known global pharmaceutical companies, who request consultancy support for several niche projects about the regulatory activities for biologics and biosimilar products. Your job will be scientifically challenging and exciting, and you will significantly increase your skills and expertise in a very short run of time!

Your tasks will be:

• Taking part to the planning and coordination of the registration process in EU and in Emerging Markets
• Responsibility of the Life Cycle Management (Variations, Renewal, etc.)
• Relationship to the external stakeholders and authorities
• Supporting the preparation for the labelling documents

Interested? If your requirements are:

• 2+ years of experience with regulatory activities concerning large molecules products
• 2+ years of experience with registration in EU or Not EU countries (To apply is enough experience in one of these areas!)
• Labelling experience
• Knowledge of EU regulations for drugs registrations
• Very flexible and dynamic personality
• High communication skills

Contract Type: Permanent

Location: Frankfurt area

Salary: Negotiable according to the experience

Starting Datum: ASAP

Send your CV in WORLD.DOC format to Dr Emma Fleury: E.Fleury@nonstop-recruitment.com

Do you feel interested just in principle? Call Dr Emma Fleury anytime: 0049 892 109 33 63

Feel free to check Dr Emma Fleurys Linkedin profile: https://www.linkedin.com/in/dr-emma-fleury-023790a2/

If you are not interested, but you know someone who could like this or another job into the pharmaceutical industry, refer us! You could gain £200 in high street vouchers if we successfully manage to place your referrals.

NonStop Recruitment is a Swiss-headquartered, pan-European specialist recruitment consultancy. NonStop comprises a number of brands each covering a particular sector and with teams of consultants focusing on specific niches. NonStop offices across Europe provide licenced contract or labour leasing solutions, as well as permanent recruitment and executive search solutions. We are dedicated to fulfilling the expectations of our customers. Our unique in-house Quality Assurance function builds on and re-enforces a strong culture of ethics and customer service. For more information, see our website http://www.nonstop-recruitment.com.

Key Words

Regulatory Affairs, Large Molecule, Biologics, Biosimilars, CTA, Clinical Trials Applications, IMPD, Investigational Medicinal Product Dossier, Life Cycle Management, Change Control-Verfahren, Variation, Renewal, Verlängerung, Einreichungen, Submission, Zulassung, Registration,Regulatory Compliance, PQR, Product Quality Reviews, CEP, Certificate of Suitability, Labelling, EMA, European Medicines Agency, MRP, Mutual Recognition Procedure, DCP, Decentralized Procedure, CP, Centralized Procedure, BfArm, Bundesinstitut für Arzneimittel und Medizinprodukte, Federal Institute for Drugs and Medical Devices, Beratung, Consultancy, Berater, Consultant, Frankfurt, Mannheim, Mittelständisches Unternehmen, Medium-sized company, Karriere, Career, Aufgeschlossen, Extrovert, International, Niche, Nische, Big Pharma, scientific, wissenschaftlich, Reisentätigkeiten, Business Trips