Regulatory Affairs Manager
Middle (2-5 ani), Entry (0-2 ani)
Atracore is looking for a Regulatory Affairs Manager (Pharmaceutical industry) in Cluj-Napoca!
Regulatory Affairs Manager
We are seeking a professional with excellent communication skills both in Romanian and English, with proven understanding of the regulatory process of the pharmaceutical industry.
We are looking for someone solution oriented, with excellent organisational and interpersonal skills, with ability to work and interact smoothly within an international team, preferably a person who had already gained experience with the regulated processes.
- Ensure delivery of regulatory activities for pharmaceutical companies (pre-licensing activities, new registration, post licensing regulatory submissions, interaction with health authorities on behalf of our customers).
- Supervise the compilation of regulatory dossiers in accordance with national requirements.
- Gain regulatory authority/body approval.
- Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project targets.
- Provide regulatory support to clients and associate companies.
- Liaise with external regulatory authorities/body as required.
- Provide format and contents review of packaging texts, Summary of Product Characteristics, Patient Information Leaflets and labelling.
- Review tasks for, support and mentor Regulatory Affairs Officers and Associates.
- Contribute to the production of client documents and reports
- Control that invoicing is correctly set.
- Contribute to data entry in our reporting tools enabling measurements of KPI/metrics for regulatory services supplied.
- Comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives.
- Assist the RA Platform / Hub Leader or a Senior RA consultant in presales: ensure providing technical support to presales and adequate technical description of the proposals and support sales for quotation evaluation
- Produce and review SOPs relating to the Regulatory Affairs function.
- Participate in training as required.
- Provide in-house training as required for staff in the Regulatory Affairs group.
- Support the Pharmacovigilance group in the production of Regulatory Authority and Ethics Committee documentation.
- Liaise with other group companies on regulatory issues and to provide support for their activities in the regulatory field.
- Contribute to follow up of the quality of service of regulatory partners
- Represent our company in regulatory associations, events and congress.
- Bachelor’s or higher graduate degree in a science related field, or equivalent experience (proven understanding of the regulatory process and experience in leading a project to successful completion).
- 2-3 years’ experience in a regulatory affairs department/pharmaceutical industry required.
- Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel.
- Knowledge of EU and Romanian registration.
- Experience in labelling in Romanian.
- Good knowledge of regulatory procedures.
- Effective oral and written communication skills in English and Romanian.
- Ability to co-ordinate, manage and motivate a team and to work well within a team.
- Process orientated with good attention to detail.
- Good computer skills and the ability to learn appropriate software.
- Excellent organisational and interpersonal skills.
- Full training on the job and external courses will be provided.
- Competitive salary package.
- Dynamic environment.
- Good platform to grow your skills with a great atmosphere.
- Flexible working environment. The position can accommodate partial home office.
- Health insurance.
- Meal tickets.