Associate Director - Patient Safety and Regulatory Affairs (m/f/d)

Associate Director - Patient Safety and Regulatory Affairs (m/f/d)

Location:

• Bad Homburg v.d. Höhe Eli Lilly and Company Apply now

Summary:

• Working Time: Full-time
• Type: Permanent employment
• Qualification Level: B

Desired Skills & Knowledge:

• Pharmacovigilance
• Talent Management
• Budget
• Mobility
• Origin
• Resource Planning
• Mobile App
• English
• Spirit
• Active Directory
• Communication
• People Management
• Regulatory Affairs
• Natural Sciences
• German
• Flexibility

Our Benefits:

• Parking
• Company ticket
• Home office
• Canteen
• Coaching
• Training measures

Job Description:

Become part of our team in Patient Safety and Regulatory Affairs in Germany and Austria, and drive the implementation of new technologies like AI. Start now and work full-time as:

Your Benefits:

• Working Atmosphere: We treat each other with respect at all levels and value our team spirit – a casual "you" is a given.

• Work-Life-Balance: You can largely manage your working hours flexibly based on trust. Our home office policy requires 50% in-office presence. We also offer a wide range of activities, including regular running groups, table tennis, gymnastics, mindfulness, and yoga groups.

• Salary Package: In addition to an attractive fixed salary, you can expect a bonus system and other financial benefits, such as our subsidized canteen, and more.

• Development: We are committed to individually supporting our employees in their career development while ensuring worldwide access to training opportunities through our "Corporate Lilly University."

• Mobility: Free parking. Commuting by public transport is supported with a job ticket. You also have the option to purchase a company bike or rent a bike on-site.

• As the appointed Stufenplanbeauftragter in Germany and Pharmacovigilance Officer in Austria, you will be responsible for maintaining and developing the Eli Lilly pharmacovigilance system in both affiliates. You will be part of Eli Lilly Global Patient Safety and work closely with the EU-QPPVs.

• You will serve as the primary point of contact for all safety-related inquiries from national authorities.

• You will act as the Risk Minimization Plan Coordinator, including the approval and distribution of safety-related external communications (e.g., training materials, Dear Healthcare Professional Letters).

• You will foster an excellent safety culture within the affiliate to ensure the safe use of all Lilly medicines.

General Management:

• You will promote a mentality of growth, mutual respect, and effectiveness.
• You will drive the implementation of new technologies, especially AI systems, to improve processes in advertising material review and pharmacovigilance.
• You will represent the department both internally and externally, e.g., in industry associations.
• You will conduct budget and resource planning to ensure the department's effectiveness.

Your Tasks:

Regulatory Affairs Leadership:

• You will successfully manage national approval procedures. Your close and reliable relationship with national regulatory authorities, characterized by mutual trust, is a key success factor.
• You will communicate EU regulatory strategies within the affiliates. You will create a strong understanding of regulatory pathways, conditions, and timelines within the affiliates, which significantly supports successful business decisions.
• Together with your team, you will support EMA procedures from the affiliates' perspective.
• You will manage and lead the information officers according to §74a AMG. You will drive the transition to using AI for the approval of advertising materials.

Your Profile:

• Degree in Pharmacy, Medicine, or Natural Sciences; PhD or MD preferred.
• Proven experience in pharmaceutical regulatory affairs and drug safety (EU focus).
• Minimum of 3 years of leadership experience in EU Regulatory or Safety functions.
• Thorough understanding of German and European drug legislation.
• Excellent communication, negotiation, and stakeholder management skills.
• Native-level German and fluent English skills.
• Strong business acumen and a focus on essentialism coupled with precision.
• High emotional intelligence and the ability to work effectively across cultures.
• Proven ability to make sound decisions and lead change.
• Strong talent management and coaching skills; a role model for collaborative, respectful leadership.
• Ability to successfully complete projects with an end-to-end mindset.

Contact:

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly

Profile:

Professional Requirements:

• Coaching and Mentoring, Cultural Diversity, Artificial Intelligence, Medical Care, Pharmacovigilance, Regulatory Affairs, Talent Management

Personal Skills:

• Decision-making ability, Leadership competence, Communication

Education:

• Dissertation

Work Experience:

• With work experience

Application:

Apply now

Industry:

Other / Unknown

Employer:

Eli Lilly and Company

Address:

Eli Lilly and Company 07980 Berga-Wünschendorf

Web:

http://careers.lilly.com

Benefits: Parking, Company ticket, Home office, Canteen, Coaching, Training measures Remote Model: Hybrid Country Code: de