AbbVie

Company Description

AbbVie is a global, research-based biopharmaceutical company that combines the focus and passion of leading-edge biotech with the expertise and capability of an established pharmaceutical leader. Redefining what is possible is our business and our passion. Our goal is to help patients live healthier lives and we are proud to be a Great Place to Work. 

Job Description

We are now recruiting a Senior Regulatory Affairs Manager supporting Europe and reporting to the Regulatory Affairs Director, Europe for Oncology. 

By integrating AbbVie you will play a pivotal role in the implementation of regulatory strategies & deliverables for a portfolio of in early/late development or marketed products for the Europe Area Regulatory Affairs (ERA) team, including EU countries and non-EU countries such as Israel, Turkey, Switzerland and the UK. You will identify and advocate the region’s requirements in the overarching global regulatory strategy, and develop risk assessment of project(s) and make sure they are considered at the GRPT. 

Within this context, your principal responsibilities will be to 

• Implement regulatory strategies & deliverables including effective planning, tracking, archiving of activities, especially submissions for early/late development and marketed products in the assigned Therapeutic Area for ERA (including non-EU CEE countries Israel, Turkey Switzerland and the UK) in alignment with the overarching global regulatory strategy and region-specific requirements. 
• Identify and advocate region’s requirements in the overarching global regulatory strategy; develop risk assessment of the project(s) and make sure it is considered at the GRPT. 
• Represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on the Global Regulatory Product Team (GRPT) to ensure those are met. Duly reports on activities in these teams and alerts TA Head when necessary. 
• Primary RA interface with Commercial Area Brand Team. Represent RA on the Area Brand Teams. Provide strategic input for registration, ensure the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval and launch by country and product). 
• Primary interface to and from the RA personnel in the affiliates and provides product updates in Area Regulatory Product Teams (ARPTs). 
• Primary interface with local health authorities (via RA personnel in the affiliates where appropriate). 
• Responsible for direct liaison with EMA for products within the Therapeutic area. Receives delegation to manage EMA meetings and other agency key meetings in liaison with affiliate regulatory managers. 
• Provide leadership and support to RA personnel in the affiliates (through ongoing communication, assist in the development, training and mentoring of regulatory leaders). 
• Assess scientific data provided by specialist units for registration purposes against ERA regulatory requirements, identifying gaps and developing mitigation strategies. Ensure effective presentation of data, complete and timely responses. 
• Maintain an active awareness of EU legislation and assess its impact on AbbVie business and R&D programs jointly with Regulatory Policy & Intelligence. 
• Implement the EU processes to achieve local HA input into R&D Programs and regulatory approval. 
• Provide Europe Area input on local implications through participation in Teams as needed (e.g., submission teams, labelling working group: development of labelling negotiations). 
• Ensure regulatory compliance within ERA for the assigned compounds/products. Implement remediation plan to address identified gaps, if any. 
• May be required to mentor less experienced staff as required. 

Qualifications

To be considered for this role, you should be a graduate in pharmacy, biology, chemistry, pharmacology, or related life sciences subject. You should also have sound knowledge of both pharmaceutical regulations and guidelines and national regulations within the assigned region, as well as a minimum of 5 years of prior relevant experience in pharmaceutical Regulatory Affairs and regulatory procedures (including CP/DCP/MRP). 

Essential Skills and Abilities 

• Demonstrated planning and organization skills. 
• Ability to prioritize and manage multiple projects. 
• Ability to work effectively and collaboratively across the AbbVie organization. 
• Understands business needs and impact of regulatory issues on these. 
• Proactive verbal and written communication style at all levels. 
• Strong leadership presence and solution driven style. 
• Ability to work independently with minimal supervision. 
• Demonstrated success in negotiating skills. 
• Experienced in working effectively across cultures and in complex matrixed environment. 
• Computer literate 

Additional Information

We are ideally looking for someone to join the team based in our Rungis, France location. However, this role can potentially be based in the UK or Germany. The country location will determine the work contract and benefits. For this role, candidates must be able to travel internationally up to 5-10% of their time. 

For us, equality, diversity, and inclusion are essential pillars. We are proud to have built an environment that allows each of our employees around the world to realize their full potential. 

You can find us at www.abbvie.com / @ABBVIE sur Twitter, Facebook, Instagram, YouTube LinkedIn. 

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.