Regulatory Affairs Senior Manager

Direct message the job poster from PharmaLex

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Job Details

Pharmalex, a Cencora company, is looking for a Senior Manager Regulatory Affairs to join the team, remote based in Spain.

Key Responsibilities

• Develop and maintain strong client relationships and help drive 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.
• Ensure personal leadership in supporting VDC strategy implementation and optimization.
• Comply with, maintain and contribute to optimizing internal processes.
• Provide day-to-day operational support for colleagues.
• Support with VDC led commercial, marketing, and business development activities including proposal input.
• Oversee project team to ensure delivery to budget and manage resolution of any invoicing queries.
• In agreement with Head of VDC REG, provide on-site regulatory support to GCS 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.
• Leadership and coaching of the direct reports; conduct of probation period, annual employee evaluation, personal development, and goal setting meetings where applicable.
• Maintain oversight of direct reports utilization, capacities, and capabilities and communicate to Team Lead. Escalation of issues to LM / HR accordingly.

Education & Experience

Minimum Skills, Knowledge & Ability 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.

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.

Seniority level

Employment type

Job function

Industries : Pharmaceutical Manufacturing

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