About Your New Employer
- One of the leading multinational companies in developing and commercializing innovative pharmaceutical products.
- Changing peoples' and patients' lives every few seconds worldwide.
- Fantastic learning opportunities and a chance to lead a Regulatory team to support operations in Europe.
About Your New Job
- You will be working closely with BIL Quality Assurance, Quality Control, and Manufacturing groups to assure the relevant product and regulatory expectations are met.
- You will be reporting directly to the Senior Director of the EU Regulatory CMC group.
- You will act as the primary regulatory CMC contact with contract manufacturing organizations (CMOs) based in Europe.
- Timely compilation and management of all necessary documentation for regulatory submissions. Ensure submissions are of high quality; that content and format of regulatory submissions comply with application regulations and guidelines governing the development, licensure, and marketing of drugs and/or biologics.
- Provide regulatory CMC support for impact assessment to change control, deviation, and inspection management.
- Coordinate and track regulatory commitments related to the site.
- Lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities.
- Demonstrate initiative and have the ability to work both independently and collaboratively in a team structure and in a global organization.
What Skills You Need
- Extensive experience in Regulatory Chemistry Manufacturing and Controls (CMC).
- Knowledge and experience in biologics and/or pharmaceuticals.
- Technical expertise in the areas of responsibility.
- Effective problem-solving mindset.
- Strong understanding of regulatory affairs submissions.
- Management skills and the ability to prioritize multiple tasks.
What’s on Offer
Strong competitive salary along with many benefits.
For a confidential discussion on this or any other current job opportunity please contact Barbara Szatkowska on 086 796 1534 / firstname.lastname@example.org
Why Apply Through Sigmar?
- We’ll help manage your job hunt, strengthen your interview skills and tidy up your CV
- We’ll provide you with an overview of the jobs market within your industry and help you tailor your jobs search
- Gain access to exclusive roles that are not advertised elsewhere
Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.