Regulatory Affairs Director Belgium/luxembourg
il y a 2 semaines
The Regulatory Affairs Country Lead has the overall responsibility for local Regulatory Affairs in Belgium/Luxembourg and for managing related issues according to our ethics and standards.
Major activities include:
- Responsible for people management of Regulatory personnel in Belgium and provides clear leadership for the Regulatory group. Secures appropriate career development for the staff and is responsible for keeping the Regulatory group scientifically and legally updated within the Regulatory area.
- Acts business oriented in terms of Regulatory Affairs advice during product development, as well as to get the best authorized profile, to put the product in the market in the shortest period.
- Supports the agency interactions to ensure a seamless submission, assessment, and quick approval of the CTAs, according to the new EU CT Regulation, in cooperation with RAE Liaison, and other internal stakeholders.
- Ensures regulatory affairs activities are conducted in compliance with local regulation, and with our policies and procedures.
- Stays updated on late pipeline filings, relevant EU and local regulations and guidelines and to develop and maintain positive relationship with key players in the regulatory environment.
- Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
- Participates in task forces of Agency/Pharmaceutical Industry for new regulations and implementation of new ones.
- Works alongside the BD, locally, regionally, and globally, to support business initiatives in the country.
- Takes part in crossfunctional product and launch teams to provide regulatory input and strategy advice.
- Maintains a positive relationship with internal and external regulatory contacts. GRACS on subregional, regional, and global level, our Manufacturing Division, EUQPPV and GCS&PV are the main contact points within the company. Acts as primary point of local regulatory agency contact for the company in case of any urgent regulatory agency requests. External contacts are regulatory authorities, as well as other key players in the regulatory environment.
- MS degree in pharmacy or other life science.
- Minimum of 45 years' experience in a Registration Department or equivalent, which should include dealing directly with regulatory Agencies, preferentially with prior experience in a supervisory position.
- Familiar with local and EU legislation procedures and guidelines governing pharmaceutical products.
- Ability to communicate well verbally and in writing, good organizational and planning skills, and management of different priorities. Ability to lead and motivate a team to achieve the common defined priorities. Ability to cooperate and strive in a crossfunctional collaborative environment, and dealing with internal and external parties.
- Native fluency in Dutch, with proficiency in English and French.
Search Firm Representatives Please Read Carefully
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Requisition ID:
R227215
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