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Director Regulatory Affairs CMC - Biologics

Director Regulatory Affairs CMC - Biologics

Job Title: Director Regulatory Affairs CMC - Biologics
Contract Type: Permanent
Location: Pennsylvania, USA
Industry:
Salary: Negotiable
Start Date: asap
Reference: HQ00073009_1526685868
Contact Name: Pavlina Bullaj
Contact Email: p.bullaj@sciproglobal.com
Job Published: May 19, 2018 00:24

Job Description

Director Regulatory Affairs CMC - Biologics

East Coast

Working together with one of our international clients, SciPro Global is actively searching for a Director Regulatory Affairs CMC Biologics to join a strong and established organization where you can provide your regulatory CMC expertise into in-licensing activities or new product development.

My client, a pharmaceutical company based on the East Coast, is looking for someone who wants to join a strong international team to make a difference and change lives. As the Director Regulatory Affairs CMC- Biologics you will be responsible for developing the global Regulatory CMC strategies for the Biologics products to facilitate overall program goals.

Role/ Responsibilities:

  • Provide Regulatory CMC expertise on cross-functional project teams, working with external partners, suppliers and contract manufacturers as required, to ensure regulatory CMC requirements are built into project plans and CMC components of regulatory submissions are positioned for successful approval and product launch.
  • Lead the preparation of high-quality CMC components of regulatory submissions including clinical trial and variations/supplements as well as registration submissions for major markets ensuring alignment with regulations, guidelines and the clients' policies and procedures and to agreed timelines.
  • Lead on CMC elements of regulatory interactions, including preparation of briefing documents, representing regulatory CMC in technical and strategic discussions with Regulatory Agencies' Worldwide and providing Regulatory CMC support for Health Authority Inspections.
  • Manage Regulatory CMC aspects of post-approval change controls, liaising with relevant client personnel as well as manufacturing partners to ensure regulatory compliance.
  • Assess and manage regulatory CMC risks and issues and champion resolution, gaining key stakeholder alignment.
  • Influence the external environment through representation on relevant organizations, attendance, and presentation at conferences.
  • As a senior member of the team, will coach and mentor other regulatory professionals, may supervise.

Experience/ Qualifications:

  • Minimum of a Bachelor's degree (or equivalent) in a science related field
  • 7 years of experience in pharmaceutical industry, regulatory or quality. However, a combination of experience and/or education will be taken into consideration.
  • Must possess knowledge and experience of developing RCMC strategies for Biological products, applying knowledge of regulatory requirements for major markets.
  • Must possess excellent communication skills, both oral and written

If this is something you would be interested in or know someone who might be, please apply to the role directly or alternatively, you can reach out to me at p.bullaj@sciproglobal.com for more information.