Senior Specialist Regulatory Affairs

1 semana atrás

Lisboa, Portugal Pharmalex Tempo inteiro

**We are growing, grow with us**
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies 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.

**Senior Specialist Regulatory Affairs**

**Your Job**
- Support with preparation of documents within the framework of regulatory affairs projects European (CP, MRP, DCP, NP, renewals, variations, and any other country-specific procedures) and non-European in agreement with projects leads.
- Support on promotional material revision, transparency and notification to authorities.
- Support with project work (e.g. compilation, preparation and reviewing of documents) after adequate instruction.
- Support with preparation and handling of internal and external correspondence.
- Technical organisation of training sessions, meetings, client visits etc. (e.g. room booking, setup and operation of presentation equipment).
- In agreement with Head Regulatory Affairs providing on-site regulatory support to PharmaLex clients.

Assist in optimizing and monitoring internal departmental organization:

- Maintain internal departmental templates.
- Assist the project managers in project planning and organization of meetings.
- Assist the Heads of Regulatory.

**Your Profile**
- University degree in pharmaceutical sciences or other natural sciences
- Perennial experience in the field of Regulatory Affairs; advanced knowledge and insights required to perform processes very efficiently and proven potential to take over more complex tasks.
- Ability to deliver on customer or internal projects / processes within daily work; ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures.
- Structured and systematic and independent way of working; limited latitude within established set of procedures, may determine priorities with little supervision.
- Ability to analyze and solve problems and to offer solutions for a given task or project; Attention to detail. High service orientation.
- Ability to train and support junior/new colleagues in daily activities; ability to lead small project with clearly defined scope.
- Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client’s team lead level.
- Good communication skills (written and verbally); capability to communicate issues and propose solutions.
- Portuguese & English language fluency (additional languages being a plus).

Agencies only by prior agreement for the specific job opportunity.

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