- Assist with the preparation and submission of regulatory agency applications, reports, or correspondence.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Assist with managing activities such as audits, regulatory agency inspections, or product recalls.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Provide responses to regulatory agencies regarding product information or issues.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
- Participate in the development of clinical trial protocols.
- Develop and maintain standard operating procedures or local working practices.
- Establish regulatory priorities or budgets and allocate resources and workloads.
- Train staff in regulatory policies or procedures.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Maintain procedures or systems for publishing document submissions either in hardcopy or electronic formats.
- Contribute to the development or implementation of business unit strategic and operating plans.
- Coordinate internal discoveries and depositions with legal department staff.
- Evaluate new software publishing systems
- Monitor new trends or updates related to electronic publishing of submissions.
- Review, edit and approve SOPs and other applicable quality systems documents.
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Sr. Regulatory Affairs Specialist - Boston, United States - Thrive
Description
A clinical-stage bio pharmaceutical client whose mission is to develop new therapies for people with rare diseases is looking for aRegulatory Affairs Specialist
with pharmaceutical and/or biotechnology experience
The Regulatory Affairs Manager will support regulatory activities of our organization to ensure compliance with domestic and international regulations and standard operating procedures.
This individual must demonstrate effective teamwork by developing collaborative relationships with internal and external personnel, as well as through highly effective oral and written communication skills.
ESSENTIAL FUNCTIONS
Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
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