Person2Person, LLC
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| Sr. Manager Regulatory Affairs - Generics Bridgewater, NJ |
| Outstanding opportunity with an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its four businesses - Pharmaceutical Services and Active Ingredients, Global Generics, Proprietary Products and Biosimilars– it offers a portfolio of products and services including Active Pharmaceutical Ingredients (APIs), Custom Pharmaceutical Services (CPS), Generics, Biosimilars, Differentiated Formulations and News Chemical Entities (NCEs). Be a part of this exciting growing Company! |
| SCOPE & DUTIES |
• Assist in the review of pre-approval and post-approval submissions from internal team in
accordance with current regulations from US FDA and Health Canada, as needed.
• Review includes a detailed scientific/regulatory review ensuring compliance to all appropriate
regulations. Communicate significant and/or potential issues.
• Provide strategic regulatory advice on pre-ANDA activities; specifically, providing clarity to inactive
ingredient database controlled correspondences, bioequivalence recommendations, and meeting
requests for NDA 505(b)(2)s.
• Actively participate in business development meetings providing updates on approval/launch
status; work with regulatory bodies to ensure appropriate followups, coordinate with IP on
patent/exclusivity status, and ensure immediate items such as PLAIR requests, drug listings, import
shipment clearances and labeling are completed.
• Independently review and provide feedback to the promotional review committee related to
promotional marketing items.
• Assess and justify the appropriate category for post-approval change classifications.
• Also, assist the R&D teams in approach strategy in accordance with compliance requirements.
• Act as primary point of contact for internal stakeholders with most recent FDA communications;
working with Regulatory Operations staff to ensure timely archiving and tracking of all external
communications.
• Support internal functional groups (i.e., Marketing, Sales, IP, Legal, QA and Pharmacovigilance)
with information requests related to submissions, customer queries, labeling changes, etc.
• Participate as the regulatory representative on US-based R&D teams in assisting with regulatory
strategy such as stability requirements, packaging requirements, bioequivalence guidance, labeling
requirements, and generics including potential NDA 505(b)(2) submissions.
• Provide guidance, advice and training to junior staff members; supervise, as needed
• Support eCTD, SPL and electronic submission gateway/upgrades.
• Provide assessments for regulatory impact relating to Change Controls, Deviations and Corrective
Actions.
• Some international travel required.
accordance with current regulations from US FDA and Health Canada, as needed.
• Review includes a detailed scientific/regulatory review ensuring compliance to all appropriate
regulations. Communicate significant and/or potential issues.
• Provide strategic regulatory advice on pre-ANDA activities; specifically, providing clarity to inactive
ingredient database controlled correspondences, bioequivalence recommendations, and meeting
requests for NDA 505(b)(2)s.
• Actively participate in business development meetings providing updates on approval/launch
status; work with regulatory bodies to ensure appropriate followups, coordinate with IP on
patent/exclusivity status, and ensure immediate items such as PLAIR requests, drug listings, import
shipment clearances and labeling are completed.
• Independently review and provide feedback to the promotional review committee related to
promotional marketing items.
• Assess and justify the appropriate category for post-approval change classifications.
• Also, assist the R&D teams in approach strategy in accordance with compliance requirements.
• Act as primary point of contact for internal stakeholders with most recent FDA communications;
working with Regulatory Operations staff to ensure timely archiving and tracking of all external
communications.
• Support internal functional groups (i.e., Marketing, Sales, IP, Legal, QA and Pharmacovigilance)
with information requests related to submissions, customer queries, labeling changes, etc.
• Participate as the regulatory representative on US-based R&D teams in assisting with regulatory
strategy such as stability requirements, packaging requirements, bioequivalence guidance, labeling
requirements, and generics including potential NDA 505(b)(2) submissions.
• Provide guidance, advice and training to junior staff members; supervise, as needed
• Support eCTD, SPL and electronic submission gateway/upgrades.
• Provide assessments for regulatory impact relating to Change Controls, Deviations and Corrective
Actions.
• Some international travel required.
| REQUIREMENTS |
• Bachelor’s degree in scientific field mandatory. Advanced degree (M.S.) preferred.
• Experience working in Regulatory Affairs supporting US FDA requirements.
• Regulatory knowledge of various dosage forms (i.e. solid oral, semi-solid, extended release,
OTC, injectables, topical patches) preferred.
• Exceptional organization abilities; ability to track approval status for a large number of products
• Excellent verbal and written communication skills
• Prior experience working with generics strongly preferred.
• Knowledge of Health Canada requirements preferred.
• RAC preferred.
Company offers an extremely competitive compensation and benefits package to all employees, 401k
with company match as well as the expected health and welfare benefits. Generous relocation.
Salary $100-120k, plus bonus.
• Experience working in Regulatory Affairs supporting US FDA requirements.
• Regulatory knowledge of various dosage forms (i.e. solid oral, semi-solid, extended release,
OTC, injectables, topical patches) preferred.
• Exceptional organization abilities; ability to track approval status for a large number of products
• Excellent verbal and written communication skills
• Prior experience working with generics strongly preferred.
• Knowledge of Health Canada requirements preferred.
• RAC preferred.
Company offers an extremely competitive compensation and benefits package to all employees, 401k
with company match as well as the expected health and welfare benefits. Generous relocation.
Salary $100-120k, plus bonus.
| Executive Recruiting Specialists in the NY/NJ/CT Region |
Apply today! For immediate consideration, please email resume to: lsydor@person2personllc.com |