Associate Director/Director, Regulatory Affairs
Our client is a biopharmaceutical company. They have asked us to assist them in their search for an Associate Director/Director, Regulatory Affairs.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Develops and implements innovative global regulatory strategies to maximize the likelihood of regulatory success across multiple regions (US, EU, Asia-Pacific).
- Integrates the European regulatory, legal, scientific/medical and business perspectives to achieve the optimal regulatory outcomes in accordance with company objectives.
- Plans and executes submission strategy for major regulatory dossiers to the FDA and/or EMA.
- Actively participates in regional organizational activities across projects.
- Conducts regulatory risk planning and mitigation.
- Supports planning and maintenance of the regulatory budget.
- Participates in key interactions with health authorities and communicates health authority feedback to drug discovery and clinical development teams.
- Develops and maintains practices and procedures of Global Regulatory Affairs team.
- Remains up to date on the global regulatory environment, regulations, and guidance (in the NA and EU regions).
- Maintains knowledge of the disease areas.
- Participates in due diligence activities and alliance management for partnered programs.
- Watches, anticipates, and acts on trends and changes in the European and international regulatory environment which may have an impact on the business.
- Develops and maintains strong functional relations with regulatory vendors across multiple regions.
- A Bachelor's degree is required. An advanced degree is preferred.
- Must have at least 5 years in regulatory affairs leading strategy development and implementation in a cross-functional project team setting. Experience managing regulatory affairs in oncology or hematology is required.
- Must have an expert understanding of policy, laws, regulations, and guidelines as they apply to US FDA for drug development and approval.
- Must understand EU regulatory principles and their impact on company's development and business goals.
- Requires regulatory experience and knowledge in multiple phases of drug development across various therapeutic areas.
- Must have demonstrated experience in strategic planning, preparing and leading CTA and IND submissions.
- An in-depth knowledge of current global regulations and guidance is essential as they relate to the overall global regulatory strategy. An understanding of legal and business aspects related to EU regulatory procedures and outcomes is required.
- Must have excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Requires the demonstrated ability to anticipate, analyze and resolve complex global regulatory-related problems and lead in situations of uncertainty.
- Domestic and occasional international travel is required.
- Must have outstanding presentation, data interpretation and communication skills.
- Must be skilled at working in a multidisciplinary environment.
- Requires experience managing external teams at CROs including monitoring execution and timely delivery of results.
- Must be a dedicated team player with an in-depth understanding of the complexities of cross functional management aspects.
- Must be a self-starter who is proactive and results-oriented with high performance standards.
- Must be comfortable working across several disease areas and able to shift gears quickly.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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