Senior Director Regulatory Global Specialty / Biosimilar Development (f/m/d) Job Details | STAD[...]

STADA; Bad Vilbel; Hybrid; EUR 120.000 - 150.000; Vollzeit

Zusammenfassung

A global pharmaceutical company in Bad Vilbel is looking for a Senior Director Regulatory Global Specialty/Biosimilar Development. The candidate will oversee regulatory activities, ensuring timely delivery of documents for new applications and lifecycle management. With 15+ years in the pharmaceutical industry and a Master's or PhD in Life Science, the ideal candidate will have a proven track record in regulatory affairs and team leadership. This role offers flexible working conditions and a dynamic work environment.

Leistungen

Flexible working hours

Job ticket and Job Bike

Childcare allowance

Health-promoting offers

Group accident insurance

Subsidized cafeteria

Qualifikationen

• 15+ years of experience in the Pharmaceutical industry.
• 8+ years of experience in Regulatory Affairs.
• Proven track record of achieving drug approvals.

Aufgaben

• Define clear roles and responsibilities for team members.
• Oversee all regulatory activities and interactions with health authorities.
• Monitor new regulatory trends and translate into impact assessments.

Kenntnisse

Team leadership

Regulatory intelligence software

Agile working style

Proactive problem-solving

Fluent in English

Knowledge of German (a plus)

Ausbildung

Master or PhD in Life Science

Tools

eCTD preparation tools

Publishing tools

Document management software

Jobbeschreibung

"Caring for People's Health as a Trusted Partner" - This purpose motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products and specialty pharmaceuticals, we offer patients, doctors and pharmacists a wide range of therapeutic options.

Around 11,700 employees live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA.

Do you want to become part of a dynamic, international team and grow with us? Then apply now as:

Senior Director Regulatory Global Specialty / Biosimilar Development (f/m/d)

Bad Vilbel|Germany (DE)|Full-time|Permanent|Portfolio & Product Development|Professionals

What you can expect

• You define clear roles and responsibilities and develop individual team members
• You prioritize and align individual deliverables across the department with overarching objectives
• You define relevant KPIs for the Regulatory department to consistently track performance
• You oversee all regulatory activities, including contribution to due diligences
• You prepare for and participate in all regulatory interactions with health authorities
• You ensure the timely and high-quality delivery of all regulatory documents for new applications and life cycle management activities (post-approval variations/submissions, lifecycle management)
• You closely monitor new regulatory trends, guidance, and guidelines, translating them into impact assessments for Specialty and Biosimilar business
• You implement best-in-class tools and state-of-the-art processes to support the department
• You act as a sparring partner for the VP Global Specialty Development in strategic discussions on Specialty & Biosimilar assets
• You represent Global Specialty/Biosimilar development in management boards
• You serve as the go-to expert for all global and local regulatory questions

Who we are looking for

• You have a Master or PhD in Life Science
• You have 15+ years of experience in Pharmaceutical industry and 8 + years of experience in Regulatory affairs incl. global positions
• You have a proven track record of achieving drug approvals from different health authorities
• You have a broad coverage of regulatory topics from CMC, Clinical, Devices, labelling, pre-approval inspections, etc.
• You have a proven track record as team leader either in line or matrix setting
• You bring a Robust understanding of Biologics / recombinant molecules, ideally also Biosimilars with you
• You are an experienced user of regulatory intelligence software, publishing tools and document management software (preparation of eCTDs)
• You are a team player, proven to be successfully working in global and cross-functional environments
• Your focus is entrepreneur with proactive and agile working style – resilient in facing ambiguity at the same time efficiently deploying project management skills
• You are open-minded and curious to explore new ways of working
• You have excellent knowledge in English, any other language(s) as German are a plus

What we offer

• An open corporate culture with fast decision-making processes and a lot of potential for your personal development
• Individual development and training opportunities
• Flexible working hours and mobile working up to 2 days per week (depending on the job profile)
• Job ticket for the RMV region and Job Bike
• Childcare allowance
• Health-promoting offers such as Wellpass or the STADA Gym (free of charge)
• Numerous additional benefits such as group accident insurance or supplementary pension scheme
• Subsidized cafeteria

We look forward to receiving your application via our career portal. At jobs.stada.com you will also find numerous other job opportunities, as we are always looking for motivated talents who can strengthen our team with their expertise and personality. Do you have further questions? Then please reach out to [e-mail]. We will consider requests to work part-time on an individual basis. Please contact us in advance by e-mail [e-mail] and let us know how many hours per week you would like to work.

STADA Group promotes its diverse culture, regardless of gender, age, social or ethnic origin, disabilities, religion, ideology or sexual orientation. We use the strength of this diversity to develop creative ideas, expand our experience and increase innovative strength. Our focus is on equal opportunities, respectful cooperation and the promotion of an inclusive working environment.