Ruderfer & Associates
Biopharmaceutical Search Consultants

#2076

Regulatory Affairs, Sr. Mgr./Assoc. Dir., Biologic CMC

Position:                     Regulatory Affairs, Sr. Mgr./Assoc. Dir., Biologic CMC     Job #2076

Location:                    Northern NJ; Raleigh, NC; or Phil., PA

Compensation:          Based Upon Experience

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Job Summary:

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

 Qualifications:

  • 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). 

  • Travel 15-20%

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