PharmaLex

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Job Details

Pharmalex, a Cencora company are expanding their Regulatory Affairs Services across APAC.

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

Key Responsibilities

• Support change applications (Administrative, Labelling, CMC, Safety) including submission strategy
• Dossier compilation including preparation of documents (e.g. local forms, Cover Letters) and Table of Contents
• Content review of CMC/Labelling documentation/Justification documents
• Alignment with functions on variation procedures, deficiency letter, e.g, CMC, Medical Science, publishing team
• Update/local PI (Labelling translation)
• Check regulatory compliance of product information/artworks
• Marketing Authorization withdrawal
• Marketing Authorization Holder transfer
• Licence renewal
• PSUR contribution
• Invoice check (e.g. Authority invoices)
• Request Translation/additional M1 documents, e.g. QP declaration, GMP
• Databases maintenance: archiving, tracking
• Management of local RA requirements (local regulatory intelligence)
• NCA 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 LCM activities
• Support of Country RA Head in issue management (e.g. PQCS Quality, Safety issues like stock out situations management, DHCPL preparation coordination and submission in accordance with local regulations and company SOP, represent RA in internal meetings and committees)
• Review of Promotional Materials
  
  

Education Requirement

• 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

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned