Supernus Pharmaceuticals, Inc.
Senior Manager Regulatory Affairs CMC
Supernus Pharmaceuticals, Inc., Rockville, Maryland, us, 20849
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Senior Manager Regulatory Affairs CMC
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Supernus Pharmaceuticals, Inc.
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Senior Manager Regulatory Affairs CMC
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Supernus Pharmaceuticals, Inc.
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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
Identify, obtain, compile and review regulatory documents concerning CMC-related issues needed for FDA submissions, including IND, NDA, NDA supplements and briefing packages for agency meetings.
Facilitate preparation of IND/NDA annual reports and keep other annual updates or reports current.
Review and assess the regulatory impact of routine proposed manufacturing related changes, non-conformance events and other GMP-related documents; research topics when requested by supervisor.
Work directly with the contract electronic publisher to get submissions published and submitted.
Track, document and communicate progress of regulatory submissions and approvals.
Order, track and process CMC-related regulatory submission documentation (e.g., certificates, declarations, sample requests and COAs).
Interface cross-functionally with CMC stakeholders (e.g., manufacturing, supply chain and quality) in the context of major manufacturing initiatives, under appropriate supervision from senior management.
Evaluate and communicate the impact of relevant regional regulations, guidance and current regulatory environment, under supervision.
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 approach work in an innovative and dynamic manner.
Self-starter able to work independently but comfortable working in a team environment.
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. Exert up to 10 pounds of force occasionally or carry objects.
Must have close visual acuity to perform tasks such as preparing and analyzing data, transcribing, viewing a computer screen or other electronic device, and extensive reading.
No substantial exposure 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.
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, national origin, disability, protected veteran status, age or any other characteristic protected by law.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Legal
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Supernus Pharmaceuticals, Inc. by 2x
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Senior Manager Regulatory Affairs CMC
role at
Supernus Pharmaceuticals, Inc.
1 day ago Be among the first 25 applicants
Join to apply for the
Senior Manager Regulatory Affairs CMC
role at
Supernus Pharmaceuticals, Inc.
Get AI-powered advice on this job and more exclusive features.
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
Identify, obtain, compile and review regulatory documents concerning CMC-related issues needed for FDA submissions, including IND, NDA, NDA supplements and briefing packages for agency meetings.
Facilitate preparation of IND/NDA annual reports and keep other annual updates or reports current.
Review and assess the regulatory impact of routine proposed manufacturing related changes, non-conformance events and other GMP-related documents; research topics when requested by supervisor.
Work directly with the contract electronic publisher to get submissions published and submitted.
Track, document and communicate progress of regulatory submissions and approvals.
Order, track and process CMC-related regulatory submission documentation (e.g., certificates, declarations, sample requests and COAs).
Interface cross-functionally with CMC stakeholders (e.g., manufacturing, supply chain and quality) in the context of major manufacturing initiatives, under appropriate supervision from senior management.
Evaluate and communicate the impact of relevant regional regulations, guidance and current regulatory environment, under supervision.
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 approach work in an innovative and dynamic manner.
Self-starter able to work independently but comfortable working in a team environment.
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. Exert up to 10 pounds of force occasionally or carry objects.
Must have close visual acuity to perform tasks such as preparing and analyzing data, transcribing, viewing a computer screen or other electronic device, and extensive reading.
No substantial exposure 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.
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, national origin, disability, protected veteran status, age or any other characteristic protected by law.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
Legal
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Supernus Pharmaceuticals, Inc. by 2x
#J-18808-Ljbffr