.. for a travel assignment in Leonardtown Maryland. Totalmed allied Job ID #** Pay package is based on 12 hour shifts and 36 hours per week (subject to confirmation) with tax-free stipend amount to be determined. Posted job title: Technician-Leonardtown in Maryland About TotalMed Allied In the fast-paced .. read more
Reporting to the Senior Director of Regulatory Affairs, the Senior Manager, Regulatory Affairs is responsible for coordination and preparation of a variety of regulatory submissions and for assisting the Regulatory Affairs team with various projects.
Responsibilities
Formulate regulatory strategies, with supervisor oversight, based on current regulatory intelligence
Collaborate with cross-functional project teams and external business partners to develop regulatory strategies, identify regulatory risks and provide regulatory advice
Serve as primary regulatory representative for clinical studies and/or as the regulatory program lead
Manage coordination, preparation, and timely submission of regulatory documents and filings
Review global regulatory submissions for consistency and quality across regions, ensuring conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments)
Coordinate preparation of responses to queries from regulatory authorities
Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs
Participate in regulatory due diligence activities
Relationships
Build and maintain collaborative relationships with external business partners and vendors to achieve project regulatory goals
Develop and maintain collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines
Coordinate activities for meetings and conferences with FDA, EMA, and other regulatory authorities
Management
May supervise employees, consultants/contractors and interns in Regulatory Affairs
Develop and implement regulatory operating guidelines and standard operating procedures
Qualifications
Bachelor’s degree, preferably in a scientific discipline, with 8+ years of drug development and 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry
Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including the preparation of regulatory submissions
Solid working knowledge of core processes: discovery, development, and manufacturing of small molecules
Experience with eCTD requirements and electronic submissions
Experience with international regulatory submissions and processes is a strong plus
Ability to work effectively across teams, functions and with outside partners
Excellent oral and written communication skills
Excellent organizational skills and attention to detail
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Responsibilities
Formulate regulatory strategies, with supervisor oversight, based on current regulatory intelligence
Collaborate with cross-functional project teams and external business partners to develop regulatory strategies, identify regulatory risks and provide regulatory advice
Serve as primary regulatory representative for clinical studies and/or as the regulatory program lead
Manage coordination, preparation, and timely submission of regulatory documents and filings
Review global regulatory submissions for consistency and quality across regions, ensuring conformance to commitments made with various regulatory agencies (eg, IND/CTA commitments)
Coordinate preparation of responses to queries from regulatory authorities
Maintain up to date knowledge and expertise with FDA/EMA regulations, ICH guidelines and other international regulatory regulations and guidelines, as needed to support global programs
Participate in regulatory due diligence activities
Relationships
Build and maintain collaborative relationships with external business partners and vendors to achieve project regulatory goals
Develop and maintain collaborative relationships with other departments to ensure effective communication regarding project regulatory goals, issues and timelines
Coordinate activities for meetings and conferences with FDA, EMA, and other regulatory authorities
Management
May supervise employees, consultants/contractors and interns in Regulatory Affairs
Develop and implement regulatory operating guidelines and standard operating procedures
Qualifications
Bachelor’s degree, preferably in a scientific discipline, with 8+ years of drug development and 5+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry
Excellent working knowledge of international regulatory requirements and environment, including an understanding of GXP
Demonstrated knowledge of the regulatory requirements in the design and conduct of clinical trials, including the preparation of regulatory submissions
Solid working knowledge of core processes: discovery, development, and manufacturing of small molecules
Experience with eCTD requirements and electronic submissions
Experience with international regulatory submissions and processes is a strong plus
Ability to work effectively across teams, functions and with outside partners
Excellent oral and written communication skills
Excellent organizational skills and attention to detail
#J-18808-Ljbffr