Manager- SPM- Regulatory Affairs
Manager- SPM- Regulatory Affairs
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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
Develop and maintain strong client relationships and actively explore opportunities for increased service support to Line Manager.
Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications renewals variations) including medical devices cosmetics food supplements and herbal products.
Preparation review and compilation of documents within the framework of regulatory affairs projects.
Communication with clients and Health Authorities.
Support with scientific advice procedures and representation of clients with health authorities.
Responsible for the planning and execution of client projects in accordance with KPIs. Coordination of project teams with colleagues and qualified external partners.
General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management.
Regulatory intelligence develop and maintain personal regulatory knowledge apply to client projects and actively share with colleagues.
Present seminars and lectures for colleagues clients and professional audiences. Active contribution and distribution of department relevant expertise.
Support with VDC strategy implementation and optimization.
Comply with maintain and contribute to optimizing internal processes.
Support with VDC led commercial marketing and business development activities including proposal input.
Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries.
In agreement with Head of VDC REG providing onsite regulatory support to clients.
The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG.
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Qualification: 6 10 years
Regulatory Affairs experience in a pharma company preferably including experience in cosmetics food supplements and/or herbal products
Experience in EU submission process
Knowledge of EU regulatory affairs disciplines
Knowledge of labelling regulations and guidance
Excellent verbal and written communication skills
Attention to detail and accuracy
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: PharmaLex India Private LimitedEqual 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 nondiscriminatory.
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 requestbyrequest basis. Messages and emails regarding anything other than accommodations requests will not be returned
Required Experience:
Manager
Employment Type
Full-Time
