Supernus Pharmaceuticals, Inc.
Manager, Regulatory Affairs
Supernus Pharmaceuticals, Inc., Baltimore, Maryland, United States,
Maryland
9715 Key West Ave
Rockville, MD 20850, USA
To provide direction and execution of Regulatory Affairs procedures and activities on assigned projects within the department. Serves as the project team liaison for ongoing development and commercial programs. Responds to team queries and provides basic regulatory strategy information to assigned project team(s). Responsible for the organization and formatting of regulatory filings in electronic Common Technical Document (eCTD) format. Works closely with third parties and internal pre-clinical, clinical, manufacturing, and QA staff in the coordination and preparation of documentation to support regulatory filings. Advises teams on the timelines and process for regulatory submissions publishing. Drafts, revises, and formats preclinical and clinical documents for submission to global regulatory agencies. Prepares and maintains submission tracking documents and monitors status of submission components. Maintains up-to-date knowledge of Food and Drug Administration (FDA) standards and procedures for regulatory submissions. Analyzes new and revised regulatory guidance and advises management of new requirements. Drives improvements in corporate document templates and Style Guide. Evaluates and implements company regulatory publishing systems/mechanisms, document management system, and regulatory software tools and templates. Oversees proper storage and archive of all regulatory documentation. Perform Regulatory submissions utilizing the Veeva RIM system. Other duties as assigned. Supervisory Responsibilities: N/A Knowledge & Other Qualifications: A PhD with one year of experience, a master's degree with four years of experience, or a bachelor’s degree with five years of experience in pharmaceutical regulatory affairs is required. Experience in the coordination and filing of regulatory documents including CTAs, INDs and NDAs, in the eCTD format. Expertise in Microsoft Word and editorial and publication software programs, experience with e-submission portals at FDA and other regulatory agencies a plus. Excellent writing and editing skills. Review skills for regulatory documents; emphasis on ability to review and edit dense and complex documentation. Experience with eCTD required. Highly organized and able to effectively multi-task; strong project management skills. Excellent communication and negotiation skills. Possess excellent interpersonal skills. Other Characteristics: Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. Ability of having an innovative and dynamic approach to work. A self-starter able to work independently but comfortable working in a team environment. Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers, and others. Capable of performing other duties as assigned by Management. Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. The worker is not substantially exposed to adverse environmental conditions. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $90,000 to $110,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual’s salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.
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To provide direction and execution of Regulatory Affairs procedures and activities on assigned projects within the department. Serves as the project team liaison for ongoing development and commercial programs. Responds to team queries and provides basic regulatory strategy information to assigned project team(s). Responsible for the organization and formatting of regulatory filings in electronic Common Technical Document (eCTD) format. Works closely with third parties and internal pre-clinical, clinical, manufacturing, and QA staff in the coordination and preparation of documentation to support regulatory filings. Advises teams on the timelines and process for regulatory submissions publishing. Drafts, revises, and formats preclinical and clinical documents for submission to global regulatory agencies. Prepares and maintains submission tracking documents and monitors status of submission components. Maintains up-to-date knowledge of Food and Drug Administration (FDA) standards and procedures for regulatory submissions. Analyzes new and revised regulatory guidance and advises management of new requirements. Drives improvements in corporate document templates and Style Guide. Evaluates and implements company regulatory publishing systems/mechanisms, document management system, and regulatory software tools and templates. Oversees proper storage and archive of all regulatory documentation. Perform Regulatory submissions utilizing the Veeva RIM system. Other duties as assigned. Supervisory Responsibilities: N/A Knowledge & Other Qualifications: A PhD with one year of experience, a master's degree with four years of experience, or a bachelor’s degree with five years of experience in pharmaceutical regulatory affairs is required. Experience in the coordination and filing of regulatory documents including CTAs, INDs and NDAs, in the eCTD format. Expertise in Microsoft Word and editorial and publication software programs, experience with e-submission portals at FDA and other regulatory agencies a plus. Excellent writing and editing skills. Review skills for regulatory documents; emphasis on ability to review and edit dense and complex documentation. Experience with eCTD required. Highly organized and able to effectively multi-task; strong project management skills. Excellent communication and negotiation skills. Possess excellent interpersonal skills. Other Characteristics: Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality. Ability of having an innovative and dynamic approach to work. A self-starter able to work independently but comfortable working in a team environment. Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers, and others. Capable of performing other duties as assigned by Management. Authorized to legally work in the United States without visa sponsorship. Physical Requirements/Work Environment/Travel Requirements: Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects. Sedentary work involves sitting most of the time. The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading. The worker is not substantially exposed to adverse environmental conditions. Compensation: At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $90,000 to $110,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual’s salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs. Base salary is one part of the overall compensation package, which includes the opportunity to participate in employee stock purchase programs and performance-based bonus programs. Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.
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