Senior Manager, Regulatory Affairs

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

We are looking for Regulatory Affairs Senior Managers to come join us in Taiwan!

Responsibilities :

Support change applications (Administrative, Labelling, Chemistry, Manufacturing & Controls, Safety) including submission strategy

Dossier compilation including preparation of documents (e.g. local forms, Cover Letters) and Table of Contents

Content review of Chemistry, Manufacturing & Controls / Labelling documentation / Justification documents

Alignment with functions on variation procedures, deficiency letter, e.g, Chemistry, Manufacturing & Controls, Medical Science, publishing team

Update / local Product Information (Labelling translation)

Check regulatory compliance of product information / artworks

Marketing Authorization withdrawal

Marketing Authorization Holder transfer

Licence renewal

Periodic Safety Update Report contribution

Invoice check (e.g. Authority invoices)

Request Translation / additional Module 1 documents, e.g. Quality Practices declaration, Good Manufacturing Practices

Databases maintenance : archiving, tracking

Management of local Regulatory Affairs requirements (local regulatory intelligence)

National Competent Authorities electronic systems for submission as locally required

Contact with the local Health Authority on behalf of the client

Cross-functional communication to all relevant departments in relation to regulatory strategy and submission as well as issues related to Lifecycle Management activities

Support of Country Regulatory Affairs Head in issue management (e.g. Quality - Product Quality Controls Standards, Safety issues like stock out situations management, Dear Healthcare Professional Letter preparation coordination and submission in accordance with local regulations and company Standard Operating Procedures, represent Regulatory Affairs in internal meetings and committees)

Review of Promotional Materials

Education :

Life Science Degree (Pharmacy degree preferable)

Experience :

At least 5-10 years of relevant experience in Regulatory Affairs

Skills and knowledge :

Experience in the life cycle management of medicinal products and knowledge of the Health Authority requirements for the maintenance of medicinal product licences

Regulatory strategy for successful submission to the Health Authority

Experience in artwork management and supply strategy

Communication with other local functions (Medical Affairs, Pharmacovigilance, Supply)

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies

Affiliated Companies : PharmaLex Australia