Manager Regulatory Affairs
This a Full Remote job, the offer is available from: APAC
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.
Responsibilities:
• Regulatory Affairs activities for lifecycle management of pharmaceutical products including but not limited to:
• 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
.
Other Accountabilities:
• 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. Product Quality Controls Standards Quality, 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
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
This offer from "AmerisourceBergen" has been enriched by Jobgether.com and got a 82% flex score.
Apply tot his job
Apply To this Job
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.
Responsibilities:
• Regulatory Affairs activities for lifecycle management of pharmaceutical products including but not limited to:
• 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
.
Other Accountabilities:
• 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. Product Quality Controls Standards Quality, 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
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
This offer from "AmerisourceBergen" has been enriched by Jobgether.com and got a 82% flex score.
Apply tot his job
Apply To this Job