Regulatory Affairs Senior Manager

Software Guidance & Assistance, Inc., (SGA), is searching for a Regulatory Affairs Senior Manager for a FULL TIME assignment with one of our premier Pharmaceutical Services clients in Hawthorn, NY.

Responsibilities:

• US Agent for all Firm's products, responsible for communication between the FDA and manufacturing sites.
• Communicate and follow-up status with FDA for any Chemistry, Bioequivalence and Patents issues and correspondences on both pending and approved applications
• Lead, guide and train the CMC team to ensure highly qualified personnel that is able to perform to meet company KPO
• Preparation, Review and filings of new ANDA, NDA, IND and DMF for the U.S. FDA in eCTD format. Preparation, Review and filing of all post marketing activities which include, timely submission of Annual Reports, CPP, release of detained products at customs etc.
• Respond to deficiencies related to Chemistry, Bioequivalence and Patent in timely manner.
• Review and approve Prototype formulation during early drug development stages to be in compliance with Inactive Ingredient Database and FDA guideline.
• Review and submit Controlled Correspondences related to product under development.
• Preparation, submission and monitoring of PLAIR activities, prior to new product launch
• Manage regulatory correspondence mainly to CDER, FDA, User fee staff, drug listing and Board of Pharmacies for state licensing submissions.
• Provide regulatory guidance to R&D, Technical Operations Sales and Marketing, Quality, Clinical, Legal.
• Contact FDA and participate in Pre-IND and Pre-NDA meetings. Prepare, review and filing of the package for these meetings.
• Communicate and follow-up with FDA for any issues, responses, status for pending and approved applications. Respond to FDA's request expeditiously.
• Review and provide guidance for Citizen Petitions. Prepare, review and file suitability petitions and controlled correspondence.
• Monitor FDA websites for new and/or updated guidance's and implement and guide the team, as required.
• Review and approve all change controls from manufacturing sites, when required.
• Provide guidance and advise management regarding improvement in CMC harmonization process of regulatory documentation at all manufacturing sites.
• Active participation in Lesson learned process, derived from regulatory correspondences.
• Support TA Labeling team, when required
• Participate in decision making process with other applicable departments.
• Prepare and evaluate performance of the individuals in the department.
• Coordinate with global and local affiliates.

Required Skills:

• MS in Life Sciences
• 4-5 years of proven experience in working with the FDA and managing regulatory team in the generic pharmaceutical industry.
• Strong background in CMC aspects of drug product registration, knowledge of U.S. drug registration (NDA, ANDA, DMF & INDs) and with U.S. drug product labeling requirements.
• Excellent verbal/written communication skills, computer skills and attention to detail.
• Excellent teamwork abilities.

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at https://sgainc.com/ .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company EEO page to request an accommodation or assistance regarding our policy.
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Last updated on Nov 10, 2023