Manager, Regulatory Affairs

3-8 years

Not Disclosed

Somerset

10 May 22, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

REMS Program Manager

Company:

Lupin

Overview:

Lupin is a fast-growing, innovative team comprising manufacturing, Research and Development (R&D), and commercial divisions. Our U.S. business focuses on both generic and branded products, with a significant pipeline and a branded focus on women’s health. Our R&D facility in Coral Springs, Florida, and our commercial manufacturing site in Somerset, New Jersey, form the core of our U.S. operations. We pride ourselves on being people-focused, emphasizing the impact we make on our customers over monetary success.

Responsibilities:

Role and Responsibilities:

Manage existing REMS (Risk Evaluation and Mitigation Strategy) programs and develop new ones as needed with supervisor support.
Analyze FDA requirements for REMS and other patient safety programs.
Collaborate with Pharmacovigilance, Commercial Operations, Finance, and Legal in the development and management of REMS Programs.
Review and approve REMS program deliverables.
Monitor and report on program launches and operations, identify risks, and highlight issues to management.
Lead the evaluation and selection of REMS vendors according to Lupin’s procurement policies.
Review ANDAs (Abbreviated New Drug Applications), supplements, amendments, and highlight major gaps in submission documents.
Manage business development product applications, including preparation of CMC/labeling documents for ANDAs, INDs, NDAs, Amendments, Supplements, and Annual Reports.
Conduct trend analysis of received deficiencies.
Provide CMC strategy and raise key issues throughout the product lifecycle to project teams and management.
Review, compile, and submit high-quality controlled correspondences and meeting requests.
Manage product distribution licenses for Lupin USA commercial entities and highlight regulatory changes that may impact operations.
Maintain and update regulatory databases to ensure information accuracy.
Perform additional responsibilities as assigned by the hiring manager.

Job-Specific Competencies/Skills:

Deep understanding of FDA REMS program requirements and processes.
Knowledge of FDA regulations and guidance on REMS, including Medication Guides, ETASU, Shared REMS, Survey Methodologies.
Experience in designing and implementing REMS systems.
Strong knowledge of CMC and labeling aspects of regulatory submissions.
Understanding of pharmaceutical product development and regulatory requirements for the USA, including lifecycle management.
Experience in authoring or managing components of regulatory submissions.
Knowledge of US FDA and ICH guidance.
Ability to interpret and apply regulatory intelligence.
Experience with eCTD publishing tools and proficiency in relevant software.
Ability to work in a complex and matrix environment.
Strong communication skills, both oral and written.
Ability to manage timelines, negotiate, and adapt.
Proficiency with Excel, Word, PowerPoint, and advanced computer skills for research.

Qualifications:

Bachelor’s or Master’s Degree in a scientific area (Pharmacy or Regulatory Affairs preferred).
6-8 years of experience in the pharmaceutical industry, with 3-5 years in regulatory affairs preferred.
Prior experience in managing, designing, and implementing REMS systems is highly advantageous.

Physical Requirements:

General physical requirements include standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking, and hearing.
Occasionally may involve bending, kneeling, crouching, stooping, and crawling.
May require lifting up to 15 pounds occasionally.
Generally performed in an office environment.

Equal Opportunity Employer:

Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.

Application Instructions:

Apply Online
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Share on your newsfeed

Search Firm Representatives:

Lupin USA and its affiliates do not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms for any current openings without a valid written search agreement will be deemed the sole property of Lupin. No fee will be paid for any candidate hired through an unsolicited agency referral.

Apply now to join our dedicated team and contribute to impactful pharmaceutical solutions that prioritize patient safety and regulatory compliance.

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