.Overview The Junior Manager, Regulatory Affairs CMC is responsible for providing regulatory relevant technical assistance to development teams and ensuring the adequacy of CMC documentation for global regulatory submissions, including specific requirements for regional registration processes.
The position supports and promotes all regulatory CMC tasks throughout the product lifecycle under the supervision of a senior Regulatory Affairs (RA) department member and in collaboration with internal and external stakeholders.
Responsibilities Responsible for the preparation and review of regulatory submissions such as INDs, CTAs, IMPDs, NDAs, BLAs, MAAs, and post-approval variations, annual reports, renewals, and responses to health authority questions (deficiency letters).Responsible for the writing of regulatory CMC sections (e.G., Module 2 and Module 3) from product development and quality source documents with the following key activities: Compilation of regulatory submission packages in close collaboration with relevant stakeholders and applicable internal procedures.
Ensuring that regulatory submission packages are scientifically adequate and include an appropriate level of detail.
Ensuring compliance with all applicable national and international regulations.
Responsible for the regulatory evaluation of CMC change controls and maintaining product compliance throughout the product lifecycle.Supporting the execution of regional regulatory strategies, in line with business objectives and in cooperation with regional partner companies and internal/external stakeholders with the following key activities:Ensuring timely submission of regulatory dossiers associated with variation packages and local specific regulatory documentation in targeted geographies and in close collaboration with partner companies and cross-functional teams.
Maintaining product compliance throughout the product lifecycle, assessment of post-approval changes, and timely closure of post-approval commitments.
Maintenance of regulatory tracking tools and regulatory management database.
Support launch activities.- Supporting mAbxience's early and late-stage pipeline products and performance of the following activities:Support preparation of early development stage regulatory submission documents such as briefing packages for scientific advice.
Identify regulatory risks during product development and/or post-approval and mitigate with the appropriate action plans incorporated into program management planning.
Regulatory Intelligence: - Monitor regulatory landscape and provide interpretive analysis and implications on local and regional regulatory guidance documents, regulations, or directives on potential impact to mAbxience portfolio and development projects.- Maintenance of regional requirements and submission templates.Qualifications Education: Degree in Life/Health Sciences (e.G., Chemistry, Biology, Biochemistry, Pharmacy), or equivalent