Manager, Regulatory Affairs

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.

##Locations

Manager


Your Job

• Evaluation, preparation and compilation of documents and sections regarding pharmaceutical quality. This includes active Substance Master Files, application documents for 'Certificates of Suitability', documents for Investigational Medicinal Product Dossier and Quality Overall Summaries/Expert Reports for human medicinal products as part of the compilation of the marketing authorisation dossier. Strong emphasis on relevant technical and regulatory requirements and customer specific demands.
• Strategy and planning with BD team for projects(new and ongoing) * Support towards the preparation of proposals for clients
• Project management covering the quality, timelines and customer satisfaction of the project * Gap analysis of the documents based on requirement
• Regulatory support to the client for the desired product throughout lifecycle management of products
• Coordination and communication with project teams, customers, other internal departments, suppliers, local partners and regulatory bodies, for all essential operational procedures.
• Assisting in optimization of internal departmental processes
• Proactively presenting and distributing department relevant technical knowledge, SOP training both of organization and of client based on requirement.
• Any other task which requires regulatory inputs for all types of products for all markets.

Your Profile

• Graduate/Post-graduate/Doctorate degree in life sciences/Pharmacy/Medical sciences or equivalent degrees
• Minimum 5 years of professional experience within the pharmaceutical industry in Regulatory affairs
• Autonomous, concentrated, and high-quality work
• Ability to work in a team
• Sense of responsibility
• Very good command of English
• Sound knowledge of current, legal and regulatory requirements of Developed markets (Japan, USA and EU)
• Ability to manage and prioritize multiple tasks, especially during stringent timelines.
• Sense of responsibility with good organizational and communication skills
• High degree of social competence and willingness to work in a team, experience in virtual teams and in matrix organizations