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Associate, Regulatory Affairs
2 weeks ago
- What you will be doing
PRIMARY DUTIES AND RESPONSIBILITIES:_
- Co-ordinate and compile regulatory submissions, responses to agency questions and other correspondence in accordance with requirements for assigned projects
- Implement an agreed upon action plan to achieve timely approval of regulatory submissions which ensure compliance with applicable regulations, policy and guidance
- Ensure electronic filing of submissions / documents / data are maintained and kept up-to-date
- Identification of client and dossier issues and development of strategies to address them in conjunction with manager
- Responsible for the quality control of documents and / or data, as required
- Participation in cross functional teams for assigned projects
- Effectively prioritize, coordinate and complete multiple projects within established timeframes as assigned
- Responsible for completion of other activities in support of products and processes as assigned (Access to Information Requests, label docket review, etc.)
- Develop and maintain professional regulatory and document knowledge in order to provide effective consulting services
- Build and maintain a positive and productive liaison with internal and external contacts, including interfacing with clients/agencies
- Experience in pharmaceutical regulatory affairs and chemistry, manufacturing, and controls (CMC)
What your background should look like
EXPERIENCE AND EDUCATIONAL REQUIREMENTS:_
- 2 - 5 years of experience in regulatory affairs experience across a range of product types. Experience with Health Canada is required. FDA experience is an asset.
- MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:_
- Direct experience and working knowledge of a wide range of regulatory submission types
- Effective project management skills; attention to detail
- Demonstrated strategic planning and problem-solving skills.
- Time management and multi-tasking skills
- Effective interpersonal skills
- Ability to consistently meet deadlines
- Demonstrated ability to work in a cross-functional, multidisciplinary team environment
- Knowledge of Microsoft Word, Excel, PowerPoint and the other Office Programs
- Excellent written and verbal communication skills
What AmerisourceBergen offers
We offer competitive total rewards compensation. Our commitment to our associates includes benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population.
Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions. Specific benefit offerings may vary by location, position and/or business unit.
Schedule
Full time
Affiliated Companies:
Affiliated Companies: Innomar Strategies
Equal Employment Opportunity
AmerisourceBergen is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
COVID-19 Vaccine Policy
- exemption/accommodation._
Accessibility Policy
- AmerisourceBergen is committed to fair and accessible employment_
- practices. When_
- requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment._
