Regulatory Affairs Consultant - CMC (client dedicated, flexible location EU/UK)United Kingdom, Remote Additional Locations: Belgrade, Serbia; Bucharest, Bucureşti, Romania; Budapest, Budapest, Hungary; Dublin, Dublin, Ireland; Madrid, Madrid, Spain; Milan, Milano, Italy; Prague, Czechia; Vilnius, Lithuania; Warsaw, Poland; Zagreb, Croatia Job ID R0000008780 Category Regulatory / Consulting
About this Role
We are currently looking for Regulatory Affairs Professionals with CMC experience to join one of our client dedicated projects. This is a role for Parexel Functional Service Provider (FSP) group and can be based in various locations in Europe (home/office based).
In the role of a Regulatory Affairs Consultant you will have strong technical skills and may be developing specialist knowledge of a particular subject and/or market. You will ensure the timely performance of work within a project scope to the quality expectations of the client. When serving as a Project Lead or Work Stream Lead, you will assure the work of the entire team or work stream is delivered on time and that it meets client’s and quality expectations
Responsible for developing and implementing the CMC regulatory strategy and submission plans for assigned projects/products to deliver timely approvals to meet business needs in regions assigned, and in line with the global regulatory strategy.
Identifies supporting documents required for (global) submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
Ensures that the regional CMC regulatory strategy for the assigned projects/products are consistent with client goals and objectives and meets HA requirements in assigned regions.
Responsible for writing regional and global CMC documentation for submissions as agreed with the GRA team, in line with agreed global regulatory strategy, and within agreed timelines.
Ensures effective communication of CMC regulatory strategy, risks, and overall plan for assigned products.
Highlights anticipated and ongoing critical issues arising through the product life-cycle in a timely manner.
Prepares or contribute to the preparation of the CMC risk analysis (or regulatory Risk Capture Document) and supports associated RA CMC challenge sessions.
Leads or provides support to cross-functional teams responsible for the preparation of responses to HA CMC questions raised in regions assigned for assigned projects/products.
Provides regulatory affairs CMC input for assigned projects/products.
Functions as regulatory CMC regional representative for assigned projects/products.
Provides regulatory assessments for CMC changes and creation of entries and updates in the company systems for assigned regions within defined timelines.
Skills and Experience required for the role:
University degree in a science discipline
3+ years specific regulatory CMC experience
Proven track record of successful authoring and contribution to delivering GRA-CMC module 3 sections of marketing authorizations and IMPD/IND for new biological and/or chemical entities (including combination products)
Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one of the ICH regions on development and post-approval products
Knowledge of GMP requirements and standard systems (e.g. change management systems and tools)
Experience with MAB preferably across development and post approval setting, preferred biologics background or significant hands-on experience in the biologics field
Deep NCE experience preferable across development and post approval setting, experience with peptide or inhaled product is a bonus.
Experience of participating in regulatory agency meetings on CMC & Medical Devices matters – preferred
Good communication skills in writing and oral communications
Fluent in English, written and spoken