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    Senior Manager Regulatory Affairs - Chicago, United States - Nemera France SAS

    Nemera France SAS
    Nemera France SAS Chicago, United States

    6 days ago

    Default job background
    Description
    Senior Manager Regulatory Affairs - Combination Products

    Full-time

    Education Level:
    Bachelor's Degree


    Legal entity:
    Nemera Insight Chicago


    Nemera is a world leader in the design, development and manufacturing of drug delivery devices for the pharmaceutical, biotechnology and generic industries.

    We leverage a long-standing experience to provide our clients with leading-edge drug delivery devices for different application areas, from services, design to large scale manufacturing.

    Lead Quality and

    Regulatory Services Initiatives:

    Manage aspects of combination product programs and projects, coordinating with both internal teams and external clients to achieve defined outcomes.


    Collaborate Across Functions:

    Partner with teams in Sales, Marketing, R&D, Human Factors, Risk Management, Quality, and Regulatory to integrate customer requirements and streamline development and submissionprocesses.


    Support and Knowledge Sharing:
    Mobilize support from internal experts to enhance project management, quality, and regulatory. Ensure comprehensive service offerings to pharmaceutical partners.

    Align Objectives:
    Ensure customer needs are met in alignment with Insight's and Nemera'sstrategic objectives, maintaining active involvement of internal stakeholders.

    Provide Expert Guidance:
    Educate and guide customers on drug delivery systems, quality, and regulatory requirements.

    Enhance Industry Understanding:
    Keep abreast of industry developments and combinationproducts through regular participation in conferences and trade shows.

    Maintain Compliance Documentation:
    Ability to author, review, and approveclear and concise quality and regulatory documents
    Oversee regulatory documentation related to combination products to ensure compliance.

    Agencies Relationship:
    Be the point of contact between the company and the regulatory agency – serve as the regulatory liaison.

    Effective Communication and Relationship Building:
    Articulate Quality and Regulatory services benefits to pharmaceutical clients and build lasting relationships with key industry leaders.
    There is a travel requirement of up to 30%
    Remote working 2 days a week
    8+ years of experience with a Bachelor of Science degree, in a related scientific discipline, or 5+ years of experience with a higher-level degree
    Expertise in development and commercial product lifecycle (Design Control or Clinical Phase 1-3, Marketed combination products).

    Prior success in filing marketing applications, supplements, and variations for biologic products within timelines is required, and global submission experience is desired.

    A thorough understanding of IND, BLA, NDA, MAA, and combination product processes such as Notified Body Opinion.

    Strong knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed combination product regulatory issues.

    Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally including customers, FDA, and other Health Authorities.
    Demonstrated ability to coach, train, and mentor teams.
    Strong negotiating skills and ability to think creatively and develop creative solutions.
    Ability to prioritize and handle multiple projects simultaneously.

    Excellent interpersonal, oral, and written communication skills as well as strong organizational skills with demonstrated ability to manage and adhere to timelines.

    Proven ability to build trust and respect within the organization and external partners.
    Interacts with Insight and Nemera employees and management.
    Interacts with customers, external business partners and Regulatory Agencies

    Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries.

    With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inhalation devices, airless dispensers, and auto-injectors.


    We put patients first when creating drug delivery devices because we know that accurate dosing and ergonomics contribute to patients completing their treatment.

    Working at Nemera means being part of a team that truly enjoys working together and always goes the extra mile to deliver on its commitments.

    We're proud of the work we do because it improves patients' lives.


    Nemera Buffalo Grove LLC is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other protected class indication.

    This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.

    The Nemera timekeeping system utilizes finger scan. Our biometric policy is available upon request at

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