Manager, Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) - Home or Office Based - 145062
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
The Global Regulatory Affairs Services department provides effective global regulatory affairs services for all stages of pharmaceutical, biologic and medical device product development and lifecycle management.
As a Manager, Regulatory Affairs (CMC) you will provide regulatory advice and support onstrategy, plus manage and provide input into projects in the provision of regulatory affairs CMC services.
This position offers continued career advancement working from an office or from home within the Global Regulatory Affairs Services department or other departments within PPD. At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team.
Summarized Purpose:This position provides regulatory advice and support on strategy plus manages and provides input into projects in the provision of regulatory affairs CMC services. Acts as liaison with internaland external clients in the provision and marketing of these services. Areas of scope include but are not limited to: CMC assessment and submissions (IND, BLA), health authority Scientific Advice, Post license authorizations/variations, Regulatory strategic advice.
Education and Experience:
- Bachelor's degree in a science-related field
- 5 years regulatory and technical experience
- Proven biologics experience
- Industry experience desirable
Knowledge, Skills and Abilities:
- Broad regulatory affairsexperience
- Good interpersonal skills
- Good knowledge of the Global Regulations
- Proven ability to work effectively in a team
- Strong knowledge of the Global Regulatory Procedures for clinical trial authorizations or marketing authorizations
- Expert knowledge of ICH and global regulatory guidelines
- Familiar with computers and their applications
- Good organizational and planning skills
- Good in-depth knowledge in one of the specialist areas
- Able to plan their work at least several months ahead
- Able to manage and plan projects and other people
- Ability to work autonomously with minimal supervision
- Mental skills required in areas of reading and interpretation of data, numeracy, language, analytical, investigative, verbal and written communication, customer contact, attention todetail, multiple project tasking
Working Conditions and Environment:
- Work is performed in an office environment with exposure to electrical office equipment.
- Occasional drives to site locations with occasional travel both domestic and international.
- Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability tolisten to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Works independently with little guidance or reliance on oral or written instructions and planswork schedules to meet goals. Requires multiple periods of intense concentration.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.
PPD is an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard toage, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group.