Job Description:
Manages all aspects of the Regulatory Affairs functions for a multi-national generic pharmaceuticals company with focus on US FDA regulations. This position advises company management on the Regulatory Affairs matters as requested and when changes occur in the regulatory landscape with potential impact to the business. Incumbent will have broad responsibilities including setting the Regulatory strategy for the company, FDA liaison, guiding development projects, supporting marketed products, and developing and maintains SOP’s. Provides Regulatory guidance to the design of the new product development programs.
(Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills and other characteristics. This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)
Supports all regulatory activity related to the US drug manufacturing and operations site.
Maintains and supports all US marketed products including; annual product reviews, annual reports, adverse drug reports, drug product listing, FDA inspections and communications, DEA regulations and communications, labeling regulations, SOP development and review.
Supports and coordinates all ANDAs and supplement filings from Jubilant Cadista Pharmaceuticals Inc. as well as from the parent company, Jubilant Organosys, in India.
Serves as the primary contact between the FDA and company for all marketed products, and additionally include review status inquiries, resolve deficiency issues, seek regulatory guidance and other related matters.
Reviews and approves the master batch records, analytical methods, validation and cleaning protocols and reports, annual product review reports, SOPs, change control documents etc.
Supports the creation, review, approval and updating of labels & labeling.
Interacts with Cadista Vendors / Suppliers and provide regulatory support to the Cadista distributors as needed.
Recommends policies and procedures for the company to remain in compliance with FDA regulations while properly and appropriately balancing business requirements with regulatory requirements.
Experience and Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the experience and qualifications required:
Education
Bachelor’s degree in Pharmacy, Chemistry, Science or related field like biotechnology, biology, etc. Master’s degree preferred.
Industry Experience Required
A minimum of ten (10) years previous experience in ANDA Regulatory work is required. Working knowledge of FDA regulations pertaining to generic pharmaceuticals and direct FDA interaction experience on ANDA’s required.
Five (5) years of supervisory experience.
Knowledge, Skills and Abilities
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required:
Budgetary Skills
Provide advice and technical assistance in the preparation of annual budgets for specific unit of responsibility.
Ability to outline proposed funding for increases and new initiatives, estimated costs and expenses, and capital expenditures needed for department.
Computer Skills
Advanced knowledge of computers with proficiency in using MS Office, MS Outlook and business software systems commonly used in the pharmaceutical industry such as SAP or similar MRP system.
Must be able to navigate through spreadsheets (excel or access), charts and PowerPoint .
Analytical /Problem Solving Skills
Mastery of concepts, principles and methods to solve difficult or unusual systemic problems characterized by their level of importance and impact to the company. Formulates logical and objective conclusions recognizing alternatives and their implications.
Strong strategic management skills and abilities. Ability to develop new ways of administering business and lead unprecedented projects.
Provide cost-benefit analyses to substantiate decisions in product selection.
Ability to use critical thinking and make recommendations to Sr. management on key regulatory issues affecting the company.
Communication Skills
Ability to speak on a one-to-one basis using appropriate vocabulary and grammar to obtain information, explain policies, procedures, and persuade others to accept or adopt a specific opinion or action.
Ability to make presentations to various groups and customers.
Skills in writing concise, logical, grammatically correct analytical reports, policies and procedures, and general office communications.
Must demonstrate a collaborative work style, with a strong ability to build relationships, gain credibility and partner with internal customers and co-workers. Strong organizational, communication and project management skills
Self-Management Skills
Ability to perform a variety of duties often changing from one task to another of a different nature under the stress of frequent interruptions and/or distractions.
Skills in setting priorities accurately to reflect the relative importance of the job in a timely manner.
Innovative skills in organizing materials, information, people in a systematic way to optimize efficiently and minimize duplication of efforts.
Human Relations Skills
Demonstrated skills and abilities in establishing rapport and gaining the trust of others.
Ability to establish and maintain cooperative working relationships.
Ability to organize objectives, delegate responsibilities, train, evaluates subordinates effectiveness and administers necessary discipline.
Working Environment
The working environment demands of this job are physically and environmentally centered on characteristics and abilities involved in this work. The work environment considers the risks and discomforts in the physical surroundings and the nature of the work assigned to ensure that all safety regulations and techniques required to perform the job are precautions practical to eliminate all risks.
Physical
Work is sedentary. No special physical demands required to perform this work.
Environmental
Work is regularly performed inside in an office and manufacturing environment. Requires use of personal protective equipment in designated areas.
The work area involves everyday risks or discomforts requiring normal safety precautions typical of such places as offices, meeting and training rooms, etc. Use of safe work practices with office equipment required.
Work area is adequately lighted, heated and ventilated.
Must exercise extreme safety and precaution at all times in all designated cGMP areas in the facility.
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