Regulatory Affairs Manager

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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.

The Regulatory Affairs Manager will provide accountability for the execution of operational tasks in the Regulatory Strategy & Procedure Management Practice Area that requires established experience and specific scientific expertise in the sector of human and veterinary medicinal products.

The responsibilities include :

• 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.
• Proven experience, or demonstrable capability, in area of responsibility or similar field, advanced knowledge and insights required to perform complex tasks and strong practical knowledge of service area and how it impacts the related areas
• University degree in Life Science.

Additional requirements :

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 Spain S.L.U. 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 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

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