Offre d'emploi : Regulatory Affairs Manager - Pharmaceutical Industry - OTC
- Regulatory Affairs Manager - Pharma OTC - Belgium
- Market leader organization with multiple launches ongoing
Our client is a leading OTC pharmaceutical organization that work toward the health professionals & the patient in order to help them in their daily health management.
In order to sustain their growth in Belgium, they are currently looking for a new Regulatory Affairs Manager to take care of the operational & strategical approach of the RA activities.
As the successful Regulatory Affairs Manager, you will have the following responsibilities:
- Participate to the development and implementation of worldwide regulatory strategies for products under development and life cycle maintenance for products on the market.
- Ensure efficient coordination with Global Regulatory Affairs and other internal key stakeholders such as CMC/Quality, non-clinical & clinical teams to meet business objectives.
- Drive the local regulatory representative activities regarding the registration activities (National, MRP/DCP) and Advertising & promotional activities.
- Will participate in DCP/MRP strategy when BEL is RMS / CMS
- Shape the Regulatory environment in particular new local regulations and EU regulations impacting Belgium and Luxembourg activities.
- Develop and maintains strong relationship with national competent Health Authorities (Be/Lux)
- Participate to regulatory due diligence assessments and recommendations for acquisitions, partnering and product distribution.
- Develop & implement Belgian policies and procedures to enhance operation of the department and ensure overall regulatory.
- Provide guidance, interpretation and opinions on complex regulatory matters outlining the different outcomes.
- Ensure that product labelling and promotional materials are in compliance with local regulations.
- Provide technical leadership, training and vision by interpreting regulatory affairs initiatives.
- Contribute to the organizational design of the regulatory affairs function and leads the selection of resources required to meet departmental and corporate objectives;
- Support the coordination of contracted activities and contact with local & competent Health Authorities.
- Manage local service providers.
- Proactively identifies opportunities for process improvements.
- Represent Corporate Regulatory Affairs with the senior management Belux committees.
- Perform other tasks and assignments as needed and specified by management.
- Has to be on the list of Responsible person for Information and Publicity (medical information)
As the successful Regulatory Affairs Manager, you will have the following requirements:
- Master's degree in Pharmaceutical Sciences / Pharmacist with complementary Industrial Pharmacy Degree
- Being enrolled on the list of the Agency
- At least 5 years of successful experience in Regulatory Science and Quality Assurance experience in a pharmaceutical industry.
- Very good understanding in Regulatory, Supply Chain, Quality Control and/or Quality Assurance within the industry.
- Direct contact and negotiation experience with Belgian & Lux competent authorities
- Demonstrated track record of success building relationships with, and influencing, national health authorities, particularly in situations requiring direct interaction/negotiation.
- Ability to influence without direct authority.
- Good negotiating and interpersonal skills, as well as an excellent verbal and written communication
- Fluent in French & English - Dutch is a strong asset
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Prior experience as main RP or Deputy RP, including releasing of batches onto the Belgian market would be consider as a plus.
The successful Regulatory Affairs Manager will join a fast growing leader in its market. The candidate will have an attractive complete salary package in line with his experience.