Regulatory Affairs Manager
Regulatory Affairs Manager
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Salary Not Disclosed
1 Vacancy
Job Description
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
Arbour Group(a Cencora PharmaLex company)one of the leading global providers of digital compliance products and services for the life sciences industry is looking for a full-timeRegulatory Affairs Hub Manager.
Responsibilities:
Preparation of regulatory processes to gain and maintain Asia Pacific and non-Asia Pacific marketing authorizations for human medicinal products (new marketing authorization application renewal variations Marketing Authorization Holder transfer)
Communication and interaction within the project team with customers local partners and health authorities in a regional and/or an international context
Coordination and management of project teams with internal and external staff and global partners incl. reporting and oversight activities and responsibilities
Responsible for the planning filing and prosecution of Regulatory Affairs project
Preparation and revision and compilation of the informative texts for healthcare professionals and patients (Company Core Datasheet Summary of Product Characteristics Patient Information Leaflet Labeling)
Revision of approval documents including tracking of updates and respective handling of databases and document management systems
Regulatory data and documents archiving handling in client databases and document management systems
Variations preparing post-approval change submissions like supplements/variations/amendments
Renewals Tracking and preparing renewal application assessment of the supporting documents for renewal application submission
Safety reports (Periodic Benefit Risk Evaluation Report/Periodic Safety Update Reports contributions Periodic Safety update report single assessments)
Support license withdrawals
Regulatory support for New Drug Applications or out-licensing
Response to deficiency letters/country requests handling of Health Authority queries with strategy and preparation of response packages
Local labelling strategy
Launch/deletion application assessments
Processing of administrative documents
Other Lifecycle Management activities as may be required
.
Education:
Graduate of any Health Science course such as Pharmacy Biology Chemistry Nursing or equivalent
Postgraduate studies certification or training in Regulatory Affairs Public Health or Business Management is an advantage
Experience:
At least 5 years of experience in a corporate setting with exposure to pharmaceutical products and regulatory processes
Proven leadership experience managing direct reports and cross-functional teams
Background in dealing with regulatory agencies and health authorities across the Asia Pacific region is preferred
Experience in project management stakeholder engagement and process improvement is highly desirable
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 timeAffiliated Companies
Affiliated Companies: Arbour GroupEqual 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 companys 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 . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Required Experience:
Manager
Employment Type
Full-Time
