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Regulatory Affairs Operations Specialist II
2 months ago
Position Overview:
We are seeking a skilled Regulatory Affairs Operations Specialist II to support our healthcare initiatives. This role involves the execution of complex global regulatory strategies and the maintenance of marketing authorizations for various products.
Key Responsibilities:
- Formulating and implementing intricate regulatory project plans.
- Assessing and prioritizing significant regulatory risks.
- Keeping abreast of pertinent regulatory requirements.
- Establishing and managing regulatory documentation in a compliant manner.
- Providing regulatory guidance to project teams.
- Addressing complex inquiries from regulatory bodies in a timely manner.
- Compiling and submitting regulatory documents in accordance with regulations.
- Updating and sustaining existing regulatory approvals.
- Overseeing regulatory activities for specific product or project portfolios.
- Creating, reviewing, and approving product labeling and standard operating procedures (SOPs).
- Leading or representing Regulatory Affairs in project teams.
- Offering direction and mentorship to junior team members in designated areas of responsibility.
Qualifications:
To thrive in this position, candidates must demonstrate proficiency in the following:
- Understanding of regulatory protocols.
- Scientific knowledge and acumen.
- Expertise in project management.
- Ability to manage multiple projects and deadlines effectively.
- Strong multitasking and prioritization skills.
- Excellent interpersonal and communication abilities.
- Robust negotiation skills.
- Technical proficiency in various systems (e.g., word processing, spreadsheets, databases, online research).
- Capacity to work efficiently in a cross-cultural environment.
- Aptitude for identifying and escalating compliance risks as necessary.
Education and Experience:
Candidates should possess a Bachelor's degree or equivalent in a scientific discipline and have a minimum of 5 years of regulatory experience within a pharmaceutical organization dealing with medicinal products, contract research organizations (CROs), or similar entities. Familiarity with FDA regulations is essential.
About Experis:
Experis is part of ManpowerGroup, a leading global workforce solutions provider that helps businesses navigate the evolving world of work by identifying, evaluating, and managing talent to drive success. Our commitment to diversity and inclusion has earned us recognition as a premier workplace, and we are dedicated to delivering value to both candidates and clients across various industries.
