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Senior Regulatory Affairs Specialist - US submission

Locatie

Taiwan

Bedrijfsprofiel

Founded in 1966, Lotus Pharmaceuticals is a leading generic company headquartered in Taiwan with comprehensive product portfolio covering CNS, CVS, oncology, women health, and anti-obesity drugs in tablets & hard/softgel capsules. Lotus runs the only plant in Taiwan approved by US FDA, EU EMA, and Japan PMDA. The Company started a new phase of growth in 2014 when Alvogen, a next generation, global pharmaceutical company, became a majority shareholder and hand picked Taiwan as its Regional Asian Headquarters. Lotus now is a fast growing specialty generic company in Asia. Their business model ensures competitive advantage through focused in-house capabilities and a network of partners for enhanced speed and flexibility. Through its majority shareholder Alvogen, Lotus has access to markets in the USA, Central Eastern Europe and Asia, while on its own Lotus has presence in Asia in Korea, Taiwan, China, India and exports to Japan and South East Asia.

Functieomschrijving/taken

Independently authors, compiles, reviews and submits high-quality regulatory submissions for FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Plans, coordinates and writes, clear, concise and accurate, responses to FDA comment letters. Submissions will include: ANDAs, Amendments, Supplements, Annual Reports, 505(b)(2) and 505(b)(1) files.

Profiel kandidaat

  • Minimum of a Bachelor’s Degree in a life science.
  • Minimum of 7 years in the pharmaceutical industry with 5 of those years in regulatory affairs dealing predominantly with US ANDAs.
  • Excellent verbal and written presentation and communication skills in English.
  • Demonstrates in-depth knowledge and understanding of FDA guidelines with proven ability to successfully apply these to work output.
  • Performs duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA.
  • Strong critical and logical thinker with ability to analyze problems and recommend solutions.
  • Effectively communicates regulatory requirements and strategies as they affect regulatory submissions to internal and external partners.
  • Exercises sound judgement. Demonstrates an advanced ability to make appropriate decisions on regulatory activities and work outputs.
  • Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
  • Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity.

Contactpersonen

Marije Hoogendoorn | Recruitment Specialist
Email : hoogendoorn@themagroup.nl
Telefone : +31 (0) 623 135 118

Tagcloud Senior Regulatory Affairs Specialist - US submission

Lotus – Alvogen – generics – Regulatory Affairs – ANDAs – submissions – FDA – pharmaceuticals

Mouterij Albert NV UgenTec BVBA Launch Diagnostics & Biokit Ltd Biognost BVBA (B) Danone Nederland (Nutricia Zoetermeer Nederland B.V.) KLANT Anton Paar Benelux Organ Recovery Systems Genencor MSD Oss Tromp Medical Engineering (  BE / mammografie ook EX-Hologic) Menarini Diagnostics Micromeritics NV Notox / WIL Research PamGene International BV Skalar Analytical BV Mosadex Ge Healthcare A1-Envirosciences Bio-Works Technologies AB Fluor QPS (Xendo Drug Development) Charles River Lab NL Tecan Benelux bvba Biomedic BV (now Part Medical) Barentz NV, België
Duitsland

Merowingerplatz 1
40225 DUESSELDORF
E-mail

België

BioVille, Agoralaan
Building A bis
B-3590 DIEPENBEEK
E-mail

Pivot Park Kloosterstraat 9 
5349 AB OSS
E-mail

Nederland

Odiliastraat 92
5401 ZZ UDEN
E-mail

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