Position: Regulatory Affairs, Sr. Mgr./Assoc. Dir., Biologic CMC Job #2076
Location: Northern NJ; Raleigh, NC; or Phil., PA
Compensation: Based Upon Experience
The Senior Manager/Associate Director, CMC Regulatory Affairs provides regulatory expertise on specific projects/queries relating to CMC for biologic products (primarily monoclonal antibodies (mAbs) in development from a global perspective and strengthen the science and scientific arguments made in the Quality section of all submissions (IMPDs/INDs, briefing documents for scientific advice, BLAs/MAAs, variations etc.) made by the company.
Duties & Responsibilities:
Providing CMC expertise in Health Authority meetings
Collaborating with International Project teams and CMC teams to advance development projects toward submission/approval.
Providing CMC input into Regulatory Submissions and Clinical Development Plans as well as pro-actively inform stakeholders of draft and new guidelines which could impact on current projects.
Ensuring quality of deliverables and services to Eisai Business units for multiple projects/product. Providing regulatory consultation to project members.
Establishing CMC regulatory strategy for projects/products. This task includes authoring of GRASP
Leading preparation of CMC regulatory communication documents and materials
Attending internal and Health Authority regulatory meetings to solve issues on CMC/Quality of the development projects
Leading preparation of submission dossiers. This includes authoring of QOS
Estimating changes proposed by QA manufacturing and take necessary regulatory measures.
Communicating with CROs in new markets to obtain market launch
Proposing solutions relative to Eisai's patient orientation/hhc mission and efficiencies within CMC
A Bachelor’s Degree in a Scientific or Technical Discipline, with minimum 4-6 years of experience in the pharmaceutical industry for Sr. Manager and 6-8 for Associate Director level. Advanced Degree (MSc. Ph.D, MBA) preferred.
Minimum 2-3 years of experience in CMC regulatory supporting biologic products for Sr. Manager & 4-6 years of relevant experience for Associate Director level.
Prior Module 2.3 preparation and assist in preparing Module 3
Strong working knowledge of the development and/or manufacture of biologics (mAbs) compounds including characterization, comparability, process validation and control strategy, and stability.
Experience of the development and manufacture of parenteral dosage forms for biologics (mAbs), including process validation.
A good working knowledge of the analytical aspects relevant to biologics (mAbs) and specification setting.
Experience in making regulatory submissions and dealing with regulatory agencies, preparation of briefing documents and holding agency meetings relating to CMC/Quality issues for biologics (mAbs).