A career with EMD Serono is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. EMD Serono is a business of Merck KGaA, Darmstadt, Germany.
In Your Role:
You will oversee operational management of drug registration and regulatory compliance acitivies which support Global Regulatory Leads. You will lead regulatory project management for mulit indication programs and manage Regulatory Project Managers to support different indications in the US, EU, Japan, and other international countries. Additional responsabilities will include:
- Support execution of drug regulatory strategy under leadership of the Global Regulatory Lead.
- Responsible and accountable for planning, managing, tracking and on-time production of regulatory deliverables for major global submissions to Health Authorities (marketing applications and clinical trial applications).
- Accountable for regulatory operational activities with respect to timelines, costs and dashboards (PM expertise)
- Coordinate Regulatory Sub Team (RST) as project manager; agenda, minutes, follow up of activities.
- Accountable for the leadership of the Submission Task Force, including maintaining compliance with dossier compilation and global submission processes for initial MAA submission.
- Close collaboration with STF members to define challenging timelines to deliver successfully a dossier according to industry benchmark timelines.
- Chair of the Submission Steering Committee (Senior Leaders in R&D) to escalate issues and risks during submission preparation
- Communicate process, timelines, and document standards to authors.
- Ensure all dossier components receive content review by relevant GRA leadership.
- Maintain the drug regulatory information management database.
- Network with GPT and sub team members to understand risks to the successful delivery of submissions.
- Point of contact regarding time lines and status of Health Authority submissions / approvals globally.
- Actively contribute to the improvement of GRA-internal planning capabilities and to increase efficiency in GRA-internal processes.
- Coach more junior regulatory project managers and actively contribute to the development of competences within the RA project manager community.
- Be an extended member of the GPT as the SME for submissions, regulatory timelines and budget demand
- Key member of the RST to represent GRA Operations
- Consolidate budget demand and tracking of actuals for GRA&RDQ and be key contact for GPT PM and Project Controller during the Forecast Meetings
- Lead the Submission Taskforce to ensure timely delivery of key submissions. Use of STF to ensure managing timelines
- Ensures availability of submission-relevant documents in appropriate quality for lifecycle submissions
- Utilize systems and tools to plan and track regulatory activities and ensure compliance to internal processes and HA obligations (e.g. RIM)
- Manages complex and global technical projects with limited risks and resource requirements.
- Manage change initiatives to improve efficiency and effectiveness of processes within GRA and beyond
- Responsible for gathering and dissemination of information about electronic e-submission capabilities from internal and external sources.
- Impacts a range of customer, operational, project or service activities within own team and other related teams that affect team performance.
- Works with substantial discretion within broad guidelines.
- Creates and maintains Regulatory Informatics and Submission Management quality documents and ensures that standards are understood and followed in RA
- Supports evaluation and implementation of new systems supporting dossier and submission management by e.g. collecting and defining user requirements.
Who You Are:
- Graduate degree requirred
- Requires substantial professional experience (more than 10 years).
- Requires in-depth knowledge and experience in own discipline and beyond to supplement formal knowledge in order to apply principles and concepts to own discipline in resolving issues as they arrive.
- Thorough understanding of the Regulatory Informatics and Submission Management area, including process and technology solutions
- Project Management experience
- Outstanding ability to work in teams and positively influence team spirit
- Ability to work diligent to ensure required quality without loosing the big picture
- Excellent result orientation and willingness to take ownership
- Strong customer orientation
- Strong communication skills, fluent command of spoken and written English
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.