Senior Regulatory Affairs Specialist
At AstraZeneca we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person. Our employees can enjoy personal growth, professional achievement and have the ability to map out long-term career plans. If you're ready to be a part of something inspiring join us at AstraZeneca.
Currently we are looking to hire Senior Regulatory Affairs Specialist.
- Ensures high-quality and timely Regulatory Affairs input to planned filings and approvals of new marketing authorizations (MA), line extensions and life cycle submissions/maintenance.
- Provides translations for centrally, MRP/DCP and nationally approved products ensuring timely and quality results, information flow between RA and other departments, cooperation between RA, QA and Supply Chain.
- Manages local packs preparation, changes implementation and artwork clearance to ensure labelling compliance.
- Works cross-functionally with local colleagues to advise and agree on regulatory strategy, clinical development plans and data requirements.
- Ensures submissions are made in accordance with accepted regulatory standards within appropriate and agreed timeframes.
- Creates and maintains the country specific part of dossier including official local product information.
- Ensures proper archiving of all documents submitted to the Health Authority and related correspondence according to AZ requirements
- Monitors and influences assessment process to expedite and optimize the outcome of the submissions/ approvals. Drive negotiations with Health Authority to ensure best possible product labelling and delivery of their commitments and deadlines.
- Works closely with local brand teams to ensure launch readiness plans are in place in order to successfully launch products.
- Proactively monitors status of post-approval commitments made to Health Authority and ensures their timely completion.
- Works closely and swiftly with cross functional teams in case of critical issues, e.g. related to batch recall or other product related issues.
- Acts as a mentor/coach for newcomers and less experienced members of RA team to assure completion of organizational goals, in a diverse and inclusive environment.
- Ensures proactivity and collaboration for successful engagement with internal & external stakeholders.
- Performs other tasks in accordance with general job description as required.
- Life Sciences Degree or appropriate professional qualifications
- English written & spoken (very good)
- Extensive broad regulatory experience in the pharmaceutical industry dealing with a wide variety of registration projects and issues
- Working knowledge of the EU and local regulatory legislation guidelines relevant to role
- Strong personal integrity, customer and quality focus
- Must be able to organize, prioritize and work effectively in a constantly evolving environment and with multiple priorities
Join AstraZeneca and help us deliver life-changing medicines. Be among our employees who continue to make us an innovation-driven company that stands firmly among the world’s leaders in biopharmaceuticals. APPLY!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.