Associate Regulatory Affairs Manager
Associate Regulatory Affairs Manager
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Managing Regulatory Submissions: Prepare regulatory submissions to obtain necessary regulatory approvals.
- Developing RA Strategies: Independently assess timelines and lead in developing regulatory strategies for new assets and line extensions. Assist RA manager or director in strategy development.
- Resolving Regulatory Issues: Identify and resolve regulatory issues and challenges that may arise during product development registration or postmarket phases.
- Collaborating with CrossFunctional Teams: Work with R&D Quality Assurance and Marketing to gather necessary information and support regulatory affairs activities.
- ProblemSolving and Decision Support: Participate in discussions and provide input on regulatory matters to support decisionmaking processes.
- Managing Variations: Set up timelines for managing variations in accordance with set strategies.
- Compliance Review: Review and evaluate product labeling packaging and promotional materials for compliance with regulatory requirements.
- Research and Stay Updated: Conduct research and stay updated on changes in regulations and guidelines as a Subject Matter Expert (SME).
- Impact Evaluation: Evaluate crossfunctional team impact implementation plans on marketed products risk management and problemsolving.
- Strategy Implementation: Reflect crossfunctional feedback and global strategy in product discontinuation withdrawal copromotion or comarketing strategies.
- Contract Review: Thoroughly review contract terms and conditions for regulatory implications.
- Pioneering New Projects: Lead new regulatory projects like combination products gene therapy and OTC products.
- Supervision: Supervise projects for regulatory matters of team members.
Qualifications :
- University degree more than 7 years of experience in a regulatory position and proficiency in both spoken and written English
- Having experience in pipeline management/ assessment with proven track records
- The candidate is expected to maintain high ethical standards and observe AbbVies code of conduct and business integrity.
- Industry from pharmaceutical companies is ideal
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Fulltime
Employment Type
Full-time
