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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 Indonesia!

Key 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

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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 CompaniesAffiliated 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 hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned