Biotech - Regulatory Affairs - Be Part Of The Team!

Born in Germany as the spin-off of a famous pharmaceutical company, over the years my client has been globally developing his business as Consultancy Company in the pharma world. For new projects on large molecules he is currently looking for a new Regulatory Affairs Manager to join his team in the Frankfurt area.

If you are looking for a nice environment, this could be a good opportunity for you! Everyone in the business does his/her best to make the company a very enjoyable place to work in, where there is support and cooperation. Therefore, if you are looking for good career chances in a friendly and open-minded environment, this could be a good opportunity for you!

Your main tasks:

• Taking part to the planning and coordination of the registration process in EU or 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

Necessary requirements:

• 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!)
• Very flexible and dynamic personality
• High communication skills
• Very good English, written and spoken

Nice to have (not necessary):

• Basic knowledge of German language

Contract Type: Permanent

Location: Frankfurt area

Salary: Negotiable according to the experience

Starting Datum: ASAP

Are you looking forwards to know your future team? 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, große Moleküle, Biologics, Biologische Produkte, Biosimilars, CTA, Clinical Trials Applications, klinische Studien, IMPD, Investigational Medicinal Product Dossier, Life Cycle Management, Lebenszyklus, 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