Junior Manager Regulatory Affairs CMC

hace 2 meses

Centro, España Mabxience A tiempo completo

Overview:
The Junior Manager, Regulatory Affairs CMC is responsible to provide regulatory relevant technical assistance to development teams and ensures 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 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 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 submissions documents such as briefing packages for scientific advices.
Identify regulatory risk(s) during product development and/or post-approval is mitigated with the appropriate action plan(s) and 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. Advanced degree in Science preferred.
Languages: Fluent English required (oral and written); other languages will be an asset.
Experience (years/area):

Minimum of 2 to 3 years’ experience working within Regulatory Affairs. Experience in biopharmaceuticals and/or biosimilars preferred.

Specific experience:

Experience in scientific writing, review and editing of CMC regulatory documents (e.g., INDs, CTAs, IMPDs, NDAs, BLAs, MAAs).
Broad knowledge of global and national regulations, guidances, and policies in pharmaceutical and biologic drug development including ICH, FDA, and EMA.
Understanding of authority expectations and requirements throughout the entire product lifecycle.
Previous experience with customer relations will be an asset.

Personal skills:

Independent and disciplined goal-oriented working style with solid problem-solving capabilities.
Ability to work cross-functional and in a dynamic fast-paced work environment.
Clear and open communication skills (oral, writing and presentation).

Travel: 10%

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