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Regulatory Affairs Consultant - Post Approval CMC

Parexel International Corporation

USA - Any Region - Home Based

Excellent opportunity for an experienced post- approval CMC Regulatory Affairs professional with past biologics and/or small molecule experience to bring your talent, excellent communication skills, strong writing experience, and CMC expertise to Parexel Consulting as a Regulatory Affairs Consultant!

In this highly visible Regulatory Affairs Consultant role, you will partner closely with a large multinational biotech company to ensure successful life cycle management of their approved treatments for various neurological diseases.

You will provide support to the client as a Regulatory CMC Commercial Lead and will be responsible for supporting the Global Regulatory Lead (GRL) with commercial (LCM and geographical expansion) activities. The Commercial Lead will focus on supporting activities as directed by the GRL and for strategy, planning, definition of content, preparation, review and approval of regulatory CMC submissions and responses to Health Authority questions.

Additionally, you will: be responsible for:

Project Management submission content support

• Develop product knowledge and update product content pages (OneNote, wiki) with centralized product information

• Schedule and attend product team meetings, record meeting minutes and manage documentation and storage of product content

• Develop Submission Planning Documents, including timelines, risks and risk mitigation

• Managing Documentum database activities in accordance with the dept QRG’s which includes, but is not limited to:

Post approval change management for submissions which may include, but is not limited to:

• Run kick-off meeting with GRL in attendance, create templates per best practice

• Follow up with authors periodically for status updates.

• Develop country specific submission versions with GRL/RL review/approve.

• Participate in Program specific Regulatory CMC Subteam and/or additional regular meeting with PXL resource to truly partner on program knowledge and updates

Lifecycle Management (LCM) Activities:

• CMC Type I/CBE Variation

• CMC Type II/PAS Variation

• Collation of submission package specifically related to Regulatory applications

• Build core and market-specific Quality Vdocs

• Collection and generation of CMC M1 documents (ie. CoAs, TSE, GMPs, Present and Proposed tables, batch records, Cover letters, applications, forms etc.)

• Maintain product filing risk register

• Regional CMC activities (where applicable) including, but not limited to:

Q&A tool support

Global Regulatory Information Tracking (GRIT) System Support

Qualifications• At least 5+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 2+ years of experience

• Successful in delivering CMC sections of marketing authorizations and LCM of commercial products

• Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority.

• Knowledge of global guidance, regulations and ICH/GMP requirements

Ability to work, with accountability, both independently and within project teams or committees to attain group goals and key project milestones.

• Demonstrated competency in planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.

• Proven ability to manage projects across global locations/time zones. Proven ability to create strong, productive working relationships in a global setting with many different cultures.

• Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively and efficiently with others internally and externally.

EEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job posted: 2021-08-10

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