Manager, CMC Regulatory Affairs for biological products F/M

Description

Overall Objectives and Purpose of the role

In the Pharmaceutical Operations team, you will be a core team member within a matrix organization. You will be in charge of managing the execution of regulatory CMC strategy for assigned products.

You will be interfacing with the internal Process, Analytical and Formulation Development teams and authoring submission sections of IND, IMPD, briefing packages, BLA, MAA and responses to agency questions based on development reports, validation reports and other technical documents. You will also interface with Regulatory Affairs, Clinical and Quality teams to ensure consistency in submission content.

You might be involved in communicating and negotiating with international Health Authorities (FDA, EMA, etc...) as necessary, directly and indirectly.

No travel is required for this position.                    

Within the CMC project team, your main role and responsibilities are the following:

Main responsibilities and key tasks

Manages CMC regulatory submissions

• With supervision, plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development
• Defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement
• Drafts the CMC sections of dossiers (initial IND & IMPD and amendments), and ensure delivery of sections in a timely manner
• Manages the writing of response to CMC questions from National Health Authorities worldwide with support from Pharmaceutical development teams and Subject Matter Experts (SMEs) as necessary to reach submission approval
• Evaluates change proposals for global regulatory impact and plans global variations amendments

As a regulatory CMC product leader or member, supports CMC teams in defining study protocols or reviewing those from CDMOs, ensures and/or enhances regulatory compliance with respect to filing requirements for assigned compounds throughout development

Contributes to the CMC strategy / documentation

• With supervision, develops and leads the execution of regulatory CMC investigational strategy for assigned products. Takes the role of regulatory CMC member on Pharmaceutical Operations throughout clinical development.
• Review and validate the content of the internal and external studies in line with the regulatory requirements and CMC strategy
• Address comments and support comment resolution on submission content
• Work with cross-functional teams to ensure production of high-quality written documents
• Interact with appropriate departments to establish priorities and deadlines for technical documentation
• Use experience in Process and/or Analytical Development to identify technical inconsistencies and participate in resolution
• With moderate supervision, represents Innate Pharma regulatory CMC in Health Authority meetings and participates in or supports CMC preparation activities for meetings with Health Authorities on CMC related matters
• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
• Fosters constructive working relationships when interacting with internal and/or external colleagues as well as CMOs

Ensure regulatory knowledge on CMC topics

• Develops and applies a comprehensive understanding of global CMC regulations and guidelines to projects to enhance probability of regulatory success and regulatory compliance
• Provide Innate functions with CMC regulatory expertise
• Participate or represent CMC regulatory strategy in project teams and in project meetings with external stakeholders / CDMOs, as necessary, for projects of the portfolio
• Communicate regulatory developments that may impact company's programs
• Keeps up to date on emerging trends within the industry in line with evolution in law, regulatory environments, technology, and global economics

Profile

Experience and Qualifications

Essential:

• Pharm. D or Bac + 5 diploma
• Experience in Biochemical Engineering, or Biotechnology, Biochemistry
• At least 5 years of experience in Regulatory CMC writing, as a regulatory CMC product lead, or equivalent industry experience (e.g., Pharmaceutical Development, Analytical Development, Production, Validation, Quality Assurance) for biotech products
• Experience of understanding  scientific principles and regulatory CMC requirements relevant to global drug development
• Knowledge of product lifecycle - Product and process development, validation and regulatory submissions, GMP manufacturing
• Experience participating in regulatory submissions of Quality module

Desirable:

• Prior knowledge of registration of Biotech products or complex biological products is an advantage
• Track record of submission of Quality module for marketing authorization (BLA and/or EU MAA)
• Track record in supporting CMC team along registration procedure (BLA and/or EU MAA) and Pre License Inspection (PLI)

Competencies, Skills and Behaviours

Technical Competencies

Essential:

• Advanced PC skills (specifically Excel, PowerPoint & EDMS applications) and ability to produce analytical reports and presentations
• Knowledge of monoclonal antibodies development and production for supporting module 3 writing
• Development and production of complex biologic molecules other than monoclonal antibodies would be a plus
• The applicant must be able to read, write and speak French and English

Desirable:

• Regulatory CMC in antibody drug conjugate development and registration

Additional Skills/ Behaviours

• Essential:

• Able to deal with issues of critical importance with minimal supervision
• Provides regulatory advice for making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance
• Demonstrates problem-solving ability, flexibility and values teamwork
• Exercises good judgement in elevating and communicating actual or potential issues to line / program management
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
• Rigorous
• Open-minded

Desirable:

• Project management skills

Innate Pharma believes in equal opportunities and welcomes all qualified applicants for employment without discrimination.