SENIOR DIRECTOR/DIRECTOR, REGULATORY AFFAIRS

Job Description
The Senior Director/Director, Regulatory Affairs will be responsible for directing day to day regulatory affairs activities that include reviewing promotional materials, participating in submissions to and interactions with regulatory agencies, and providing regulatory support to all relevant functional areas.

Other Essential Duties and Responsibilities Include:

Contribute to formulation and execution of regulatory affairs strategy pertaining to all relevant Company goals and objectives.

Direct domestic and global regulatory projects, determine submission requirements, plan
submission process, and work with cross functional team to coordinate and approve regulatory documentation for inclusion in US and global regulatory submissions.

When appropriate, perform regulatory review of manufacturing, quality, research, and
commercial documents, provide facilitative commentary and feedback, and assume responsibility for regulatory approval for relevant documents.

Consult with and manage external regulatory affairs consultants.

Monitor trends and changes in regulations and advise internal stakeholders on the potential impact to current and future strategy and tactics.

Work with internal stakeholders to ensure that all relevant Company activities are in conformance and compliance with regulatory law and guidance.

Represent Regulatory Affairs on project teams to communicate the necessary regulatory
requirements and facilitate the fulfillment of these requirements.

Other responsibilities as assigned.

Educational / Experience Requirements:

BA/BS required, MBA preferred

Regulatory Affairs Certification (RAC), preferred

Experience in domestic and international regulatory submissions/interactions

Pharmaceutical and medical device experience, preferred

Other Skills and Abilities:

Demonstrated leadership and facilitation in a cross functional team environment;.

Excellent writing and editing skills.

Excellent communication and negotiation skills.

Demonstrated strategic thinking/implementation skills.

Demonstrated PC skills including Microsoft Office Suite.

Demonstrated ability to handle multiple tasks independently.

Demonstrated organization and analytical skills.

Company

Discovery Labs

Job Code

State or Province

Pennsylvania

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