level-one heading

Kolabtreeを選ぶ理由

開始はすばやく簡単です。初期費用はかかりません。

サービス依頼と専門家への見積依頼は無料です。

Kolabtree の作業範囲に同意する前に、専門家と要件を詳しく相談できます。

専門家と直接連携し、必要な成果を正しく得られます。

専門家を採用したらプロジェクトに資金を入れ、作業完了後に成果物を承認できます。

Rachid E. に連絡

連絡する

Kolabtreeを選ぶ理由

この専門家をプロジェクトに採用したいですか？見積もりを依頼無料で。

プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Rachid E.に依頼

Netherlands

More than 5 years of experience as Regulatory Affairs Specialist

プロフィール概要

My qualification is an MSc in Biomedical Sciences.

I am a Regulatory Affairs Specialist. The primary responsibilities are:
- Working with CTD dossier
- Coordination of the project (compilation and binding of the regulatory dossiers for the new application of marketing authorisation/renewal/variation; submission of products registration application; literature review; labelling & artwork)
- Preparing new CMC applications for marketing authorisation/renewal/variation of medicinal products, OTC and medical devices for regulatory submission 
- Regulatory consulting related to EU/US regulation
- Adhere to required use of technical resources, through the use of work practices and QC/QA regimes, to maintain regulatory and internal compliance.

What can I do for you?
- Pharmaceutical Regulatory Affairs Projects.
- Some of my other specialties include technical writing to product submissions/dossiers. I can assist you with your drug label development and/or editing to ensure you are compliant to your jurisdiction.
- My favorite thing is label compliance review! I can review your pharmaceutical and OTC drug labels for compliance to US FDA, EU Directives, Health Canada and more!

Do not hesitate to contact me to discuss potential collaborations. I am looking forward to hearing from you!

専門分野