Senior Regulatory Manager / 256 Job in Rockaway 07866, New Jersey Us
Position Description:
About Warner Chilcott
Warner Chilcott is a leading specialty pharmaceutical company currently focused on the women's healthcare, gastroenterology, dermatology and urology segments of the North American and Western European pharmaceuticals markets. We are a fully integrated company with internal resources dedicated to the development, manufacture and promotion of our products. Our franchises are comprised of complementary portfolios of established branded and development-stage products that we actively manage throughout their life cycles. We believe that our proven product development capabilities, coupled with our ability to execute acquisitions and in licensing transactions and develop partnerships will enable us to sustain and grow our business.
POSITION SUMMARY
The Senior Regulatory Manager working closely with a Director/Senior Director will focus on US Regulatory requirements and represent the regulatory affairs function on one or more project teams supporting development and/or marketed product activities. The Senior Regulatory Manager will serve as the primary point of contact with FDA for assigned projects/products. Within the regulatory function, the Senior Regulatory Manager will collaborate closely with other regulatory functions including Regulatory-Operations, Regulatory-CMC, Regulatory-Advertising Promotion, and Regulatory Program Management-EU/Rest of World to ensure business needs are met.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
• Provides US regulatory strategy and tactical support to cross-functional development and product teams.
• Coordinate and lead cross-functional groups for regulatory activities and deliverables ensuring applicable requirements regulations are met.
• Author and/or compile regulatory documentation to be submitted to FDA to support ongoing activities pre-IND through phase IV, including, but not limited to, annual reports, meeting requests and associated briefing packages, protocol amendments, new drug applications, etc.
• Serve as the primary contact for FDA on assigned projects.
• Oversee additional regulatory projects as assigned
CORE COMPETENCIES include the following.
• Job knowledge - possesses working knowledge of US regulations, regulatory environment, general drug development and scientific/therapeutic areas of interest
• Leadership - provides strategic direction, sets goals/milestones and independently monitors progress, can delegate responsibility
• Communication skills - very strong written and verbal communication skills, ability to be effective not only in small 1-on-1 settings but in larger group settings, can communicate effectively with colleagues at various sites around the world
• Interpersonal skills - able to work well within cross-functional teams, fostering a positive and collaborative culture and unifying team dynamics
• Critical thinking skills - ability to independently analyze problems and develop potential solutions outlining associated pros and cons; can articulate and discuss complex issues appropriately with varying audiences
Qualifications:
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 knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE Please indicate the minimum education/experience requirements required to perform this position.
* Education: Bachelors degree or equivalent
* Experience: 3+ years relevant regulatory affairs and/or drug development experience
OTHER SKILLS AND/OR ABILITIES. Please list any other skills and/or abilities that are required to perform the essential functions of this job.
• Basic working knowledge of core drug development and registration processes
• Demonstrated ability to work independently with limited guidance and have demonstrated ability to appreciate and align business needs and objectives while maintaining independence and deliver solutions as a regulatory team member.
CERTIFICATES, LICENSES, REGISTRATIONS
PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.
While performing the duties of this job, the colleague is regularly required to sit; use hands to finger, handle, or feel; talk or hear. The colleague is occasionally required to stand and walk. Specific vision abilities required by this job include close vision and ability to adjust eye focus.
WORK ENVIRONMENT The work environment characteristics described here are representative of those a colleague encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.
The noise level in the work environment is usually quiet.
Language Skills
The ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Mathematical Skills
Ability to calculate figures and amounts such as addition, subtraction, multiplication, division, discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
Reasoning Ability
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.