Job description

Job description

Department

Regulatory Affairs

Job Title

Senior Manager Regulatory Affairs

FLSA Status

Exempt

Reports To

Chief Executive Officer

1. Role Purpose:

The Senior Manager of Regulatory Affairs is responsible for regulatory submissions and maintaining submission information in a proper RA systems. The incumbent works cross-functionally with internal departments and external resources on source documents and Regulatory related issues, ensuring those are in compliance with FDA regulations and company SOPs. The incumbent is also responsible for preparation of labeling and artwork, eCTD compilation and submission for ANDAs and NDAs registration and maintenance.

2. Key Duties & Responsibilities:

• Review of Drug Master Files (DMF), amendments, supplements and annual reports.
• Comply to FDA guidelines/Company Policies of Data Integrity
• Oversee the interviewing, hiring, training, and development of all department personnel, ensuring employees can function effectively in a team environment.
• Comply with FDA guidelines/Company Policies of Data Integrity.
• Other duties as assigned.
• Regulatory Submissions:
• Work cross-functionally with internal departments and external resources (e.g., CROs, CMOs) to ensure that source documents are received in a timely manner for submissions.
• Prepares original ANDAs and NDAs, amendments ensuring these are in compliance with applicable FDA regulations.
• Performs documents formatting and publishing to ensure that submission documents adhere to FDA eCTD requirements and company SOPs.
• Has responsibility for archiving of all original submissions in a secure system and maintains and keeps an up-to-date record of all correspondence with FDA.
• Labeling and Artwork:
• Work cross-functionally with internal departments and external resources to ensure that labeling and artwork are received, reviewed and approved in a timely manner for submissions.
• Prepares contents of labeling for new registration and/or revised labeling of drug products in accordance with RLD and applicable FDA regulations (e.g., 21 CFR 201 and 208).
• Proofreads, reviews and approves labeling printer proofs to ensure accuracy of contents, completeness and integrity.
• Monitors RLD labeling updates and initiates change requests, if necessary, for labeling of all new registration and marketed products in accordance with RLD.

3. Typical Supervisory Responsibility:

Manage and oversee the regulatory affairs department.

4. Education & Experience:

Education Requirement

Specialization (If any)

BS in Chemistry or related science field preferred

Experience Requirement

Around 10 years of experience in the Pharmaceutical industry preferred

5. Technical competencies/ Certifications/ Licenses:

Technical competencies

• Proficient with use of technologies (e.g. Adobe Acrobat, ESG, XML, SPL) and eCTD publishing tools
• Strong knowledge of United States of Pharmacopoeia.
• Expert knowledge of Title 21 of Code of Federal Regulations, various US FDA guidance and ICH guidelines
• Knowledge/Experience of Chemistry, Manufacturing and Control sections of original Abbreviated New Drug Applications (ANDA), amendments, supplements, and annual reports.
• Knowledge/Experience of Chemistry, Manufacturing and Control sections of New Drug Applications (NDA), amendments, supplements, and annual reports.
• Strong working experience in ANDA, NDA eCTD submissions.
• Working knowledge of FDA regulations (e.g., 21 CFR 314.50 and 314.94 and 21 CFR 201 and 208) and applicable FDA guidance.
• Must demonstrate strong leadership skills
• Possess strong attention to details. Excellent multi-tasking skills and ability to manage multiple competing projects while meeting project timelines
• Performs other duties as assigned.
• Complies with company polices and SOPs.
• Good written and oral communication skills
• Experience in statistical analysis, process capability reviews with software
• Ability to act independently
• Excellent interpersonal, verbal and written communication skills

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/A

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Newtown, PA 18940: Reliably commute or planning to relocate before starting work (Required)

Work Location: In person

Job Type: Full-time

Pay: $100,000.00 - $200,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Supplemental pay types:

• Bonus pay

Work Location: In person

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