Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

• Supporting Immunology Therapy Area
• Reporting to the Associate Director, Regulatory Affairs.
• Office Based, with 3/2 flexible working offered.
• Comprehensive salary, bonus and benefits package.

Role overview:

The Senior Regulatory Affairs Manager will implement regulatory strategies & deliverables for a portfolio of early/late development or marketed products for the Europe Area Regulatory Affairs (ERA) including EU countries and non-EU countries such as Israel, Turkey, Switzerland, UK and some CEE markets.

In this role you will identify and advocate the region’s strategic requirements, and ensure the Europe region-specific strategy is represented in the overarching global regulatory strategy; develop risk assessment of the project(s) and make sure it is considered at the Global Regulatory Product Team (GRPT).

Key Responsibilities:

• 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 regional 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 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 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.
• Contribute, as required, to the development of global and regional processes to maximize operational efficiency of regulatory activities within the region

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 extensive demonstrated 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.
• Willingness to travel as necessary (~5%).
• Computer literate

Additional Information

AbbVie is an equal opportunity employer and 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. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html