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Trenton

    Associate Director of Regulatory Affairs Strategy - Trenton, United States - Meet Recruitment

    Meet Recruitment
    Meet Recruitment Trenton, United States

    20 hours ago

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    Description


    We are partnering with a growing biotech that is seeking a highly skilled and experienced Associate Director of Regulatory Affairs Strategy to join their Regulatory Affairs team.

    The successful candidate will play a pivotal role in developing and executing regulatory strategies to support the successful development, registration, and commercialization of their pharmaceutical products globally.


    Responsibilities:
    Develop and execute comprehensive regulatory strategies in alignment with business objectives and regulatory requirements.

    Lead regulatory activities for assigned projects, including preparing regulatory submissions, managing regulatory interactions with health authorities, and ensuring compliance with applicable regulations and guidelines.

    Provide strategic regulatory guidance to cross-functional teams throughout the product development lifecycle, from early development to post-marketing activities.

    Collaborate with internal stakeholders, including R&D, Clinical Development, Quality Assurance, and Commercial teams, to integrate regulatory considerations into overall product development plans.

    Monitor regulatory landscape and proactively identify potential risks, opportunities, and changes in regulatory requirements that may impact product development or commercialization strategies.

    Mentor and provide guidance to junior regulatory affairs team members, fostering their professional growth and development.

    Qualifications:
    Bachelor's degree in life sciences or related field required; advanced degree (e.g., Master's, PhD, PharmD) preferred.

    Minimum of 6 years of experience within the pharmaceutical or biotechnology industry, with at least 3 years of experience in regulatory strategy development.

    Strong understanding of global regulatory requirements and guidelines for drug development and commercialization, including FDA, EMA, and other major regulatory agencies.

    Demonstrated track record of successfully leading regulatory activities for pharmaceutical products throughout the product lifecycle.
    Experience in Oncology preferred

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