Supernus Pharmaceuticals
Senior Manager Regulatory Affairs CMC
Supernus Pharmaceuticals, Rockville, Maryland, us, 20849
Job Summary
The Senior Manager, CMC is responsible for managing the regulatory aspects of projects/products including the preparation and submission of correspondence and applications to regulatory agencies.
Essential Duties & Responsibilities
Identifies, obtains, compiles and reviews regulatory documents concerning CMC-related issues that are needed for FDA submissions including IND, NDA, NDA supplements and briefing packages for agency meetings.
Facilitates preparation of IND/NDA annual reports and keeps other annual updates or reports current.
Reviews and assesses the regulatory impact of routine proposed manufacturing related changes, non-conformance events and other GMP related documents; researches topics when requested by supervisor.
Works directly with the contract electronic publisher to get submissions published and submitted.
Tracks, documents and communicates progress of regulatory submissions and approvals.
Orders, tracks and processes CMC-related regulatory submission documentation (e.g., certificates, declarations, sample requests and COAs).
With appropriate supervision from senior management, interfaces cross-functionally with CMC stakeholders (e.g., manufacturing, supply chain and quality) in the context of major manufacturing initiatives.
Under supervision, evaluates and communicates impact of relevant regional regulations, guidance and current regulatory environment.
Other Duties as Assigned.
Supervisory Responsibilities
N/A.
Knowledge & Other Qualifications
Relevant Ph.D. with minimum 3+ years or Master’s/Bachelor’s with minimum 6+ years relevant experience in pharmaceutical regulatory affairs.
Previous experience with global regulatory submissions a plus.
Solid knowledge of eCTD Quality sections and regulatory submissions experience.
Excellent knowledge and understanding of FDA/ICH regulations and relevant guidance (CMC).
Proficient in Microsoft Windows applications.
Other Characteristics
Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
Ability to have 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 activities 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 $135,000 to $155,000. 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.
Equal Opportunity / Affidative Action 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, national origin, disability, protected veteran status, age or any other characteristic protected by law.
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Essential Duties & Responsibilities
Identifies, obtains, compiles and reviews regulatory documents concerning CMC-related issues that are needed for FDA submissions including IND, NDA, NDA supplements and briefing packages for agency meetings.
Facilitates preparation of IND/NDA annual reports and keeps other annual updates or reports current.
Reviews and assesses the regulatory impact of routine proposed manufacturing related changes, non-conformance events and other GMP related documents; researches topics when requested by supervisor.
Works directly with the contract electronic publisher to get submissions published and submitted.
Tracks, documents and communicates progress of regulatory submissions and approvals.
Orders, tracks and processes CMC-related regulatory submission documentation (e.g., certificates, declarations, sample requests and COAs).
With appropriate supervision from senior management, interfaces cross-functionally with CMC stakeholders (e.g., manufacturing, supply chain and quality) in the context of major manufacturing initiatives.
Under supervision, evaluates and communicates impact of relevant regional regulations, guidance and current regulatory environment.
Other Duties as Assigned.
Supervisory Responsibilities
N/A.
Knowledge & Other Qualifications
Relevant Ph.D. with minimum 3+ years or Master’s/Bachelor’s with minimum 6+ years relevant experience in pharmaceutical regulatory affairs.
Previous experience with global regulatory submissions a plus.
Solid knowledge of eCTD Quality sections and regulatory submissions experience.
Excellent knowledge and understanding of FDA/ICH regulations and relevant guidance (CMC).
Proficient in Microsoft Windows applications.
Other Characteristics
Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
Ability to have 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 activities 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 $135,000 to $155,000. 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.
Equal Opportunity / Affidative Action 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, national origin, disability, protected veteran status, age or any other characteristic protected by law.
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