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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-time Regulatory 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 time

Affiliated CompaniesAffiliated Companies: Arbour Group

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