Job title:
Team Leader Global Regulatory Affairs API
Company:
Xellia Pharmaceuticals
Job description
Team Leader Global Regulatory Affairs API
Regulatory AffairsAbout the Job
As a API Regulatory Affairs Team Leader, you will be responsible for the professional lead of team and regulatory activities related to registration of active pharmaceutical ingredients in global markets of interest. Your responsibilities will include supporting, mentoring, and developing the API RA team, but also assuring submissions ofhigh quality DMFs in timely manner and providing regulatory support to Xellia’s customers and stakeholders. In this role, you will report to the Senior Director, Global Regulatory Affairs.Main Responsibilities
- Provide overall direction, advice, regulatory support, and guidance to the GRA API team members
- Manage 1:1 and Xellia Grows conversation with GRA API team members
- Setting up targets and follow up on performance of GRA API team members
- Give guidance on prioritization of activities to GRA API team members
- Promote optimal use of human resources and competencies inside GRA API team
- Promote motivation and positive spirit in the team
- Oversight on GRA API activities and projects such as renewals, Deficiency Letter trends/repeating questions, and new initiatives from relevant authorities
- Aligning procedures within GRA API
- Actively participate in meetings and share insights on regulatory strategies
- Create and share monthly report based on inputs from GRA API team members
- Schedule and host team meetings and various team activities
- Review regulatory relevant sections of API contracts such as Supply Agreements, Quality Agreements, etc.
- Contact person for API regulatory matters during customer and authority audits at all Xellia sites
- Participate in scientific advice meetings with authorities
- Adhere to Xellia’s Leadership Promise of being present and authentic, make people shine, build bridges, and being courageous
- Continuous development in the area of regulatory affairs
- Providing all needed regulatory support, including opinion or advice to other stakeholders
- Life-cycle management of relevant Drug Master Files (DMFs) and Active Substance Master File (ASMFs) including annual reports/annual amendments, and variation packages
- Reviewer and approver of annual amendments and variation packages for relevant DMFs
- Preparation of DMFs for Rest of the World (ROW) countries based on existing EU and US DMFs
- Handling of deficiency letters
- Preparation of Quality Overall Summaries
- Retrieve, review for accuracy, completeness and compliance with regulations, approve and collect all supporting documentation for regulatory submissions, i.e. manufacturing process, specifications, analytical procedures, and validation reports, batch records etc.
- Participate in projects as regulatory representative providing regulatory support and prepare relevant regulatory strategies for the project
- Contribute to the product development and maintenance of the existing portfolio from regulatory aspects
- Evaluate change controls
- SOP preparation
- Continuous monitoring of guideline (FDA, EMA, EDQM) home page and ensure timely implementation
- Work in MyProcess/Trackwise and other regulatory systems as applicable
- Adhere to company policy e.g. purchasing, travel etc.
- Act according to the company behavioral standards at any point in time
What We Expect
- Minimum a bachelor’s degree in Pharmacy, Chemistry, Biotechnology or related studies
- Preferably more than 10 years of experience in regulatory affairs and more than 5 years of experience as people leader
- Excellent English communication skills (spoken and written)
- Knowledge and deep understanding of GMP and hands-on experience in applying it to an operational environment
- Thorough proficiency in MS Office
- Must work well under deadlines and have excellent attention to detail
- Proactive working approach and developed stakeholder management skills
- Excellent interpersonal and communication abilities
What We Offer
- Competitive compensation and benefit package
- „Nordic-style” culture – dynamic teamwork, good working atmosphere, flexibility, maintaining work-life balance
- Opportunity to learn and develop
- Good team spirit and friendly colleagues
- Stable international company background
- Multinational working environment
- Home office opportunity
Xellia Pharmaceuticals is a specialty pharmaceutical company and a global leader in providing anti-infective treatments and other critical care therapies for serious and often life-threatening conditions. Xellia has an extensive heritage in developing, manufacturing, and commercializing anti-infective products.Headquartered in Copenhagen, Denmark, and owned by Novo Holdings A/S, Xellia Pharmaceuticals has more than 1400 employees globally, including state-of-the-art manufacturing sites in China, Denmark, and Hungary. Our strong market position is built on more than 120 years of pharmaceutical industry experience.Further information about Xellia can be found at:
Connect with us on
Expected salary
Location
København
Job date
Wed, 15 Jan 2025 02:03:19 GMT
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