Regulatory Affairs Manager
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The {company}, a multinational medical device and health care company, is looking for a Regulatory Affairs Manager. This position oversees teams within the Regulatory Affairs Sub-Function, focusing on policy and strategy implementation rather than development. The ideal candidate will have experience in developing projects or sites from scratch.
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As the Manager of Regulatory Affairs, key responsibilities include:
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* Overseeing strategy implementation and operations for product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
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* Interacting with regulatory agencies to expedite approval of pending registrations.
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* Serving as a regulatory liaison throughout the product lifecycle.
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* Participating in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
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* Ensuring timely approval of new drugs, biologics, or medical devices and continued approval of marketed products.
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* Serving as a regulatory representative to marketing, research teams, and regulatory agencies.
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* Advising development and/or marketing teams on manufacturing changes, line extensions, technical labeling, regulations, and interpretations.
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Required skills and experience include:
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* Manufacturing operations and change experience.
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* People management experience.
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* Experience resolving nonconformance issues.
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* Strong attention to detail.
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* Solid communication skills and ability to communicate at all levels.
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* Experience with EU and US regulatory bodies.
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* Strong organizational skills.
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Prioritizing adaptability and clear external communication, this role demands:
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* Ability to adapt to change.
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* Capacity to maintain clear and concise communication with governing bodies.
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* Experience reviewing manufacturing changes.
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* Optimization of regulatory acceptance changes.
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* Supporting manufacturing operations.
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* Handling Ad Hoc Issues.
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* Capability to work with tight deadlines.
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Key qualifications include:
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* A minimum Level 8 degree in Engineering or Science or related discipline.
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* A minimum of 5 years of experience in a similar position and experience with EU Regulatory bodies in regards to applications and submissions or equivalent international experience.
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Salary: $120,000 - $180,000 per year