Regulatory Affairs Specialist
1 week ago
About the Role:
We are seeking a highly skilled Senior Specialist, Regulatory Affairs to join our team at SPCSHP. As a key member of our Regulatory Affairs team, you will be responsible for managing all legal and regulatory submissions related to healthcare and pharmaceutical advertising campaigns.
Key Responsibilities:
- Manage day-to-day submissions and act as a subject matter expert on client submission requirements and platforms.
- Stay informed about the constantly evolving landscape of regulatory requirements and provide guidance to clients and internal teams.
- Work cross-functionally with Project Management to ensure submission timelines are met and all material is gathered for accurate and timely submissions.
- Collaborate with Creative teams to ensure compliance with guidelines and regulations.
- Coordinate with Account and Client Service teams to ensure that submissions meet both client expectations and internal quality standards.
- Develop departmental processes and documentation to conform with client and SPCSHP guidelines.
- Continuously monitor industry trends and changes in regulatory requirements to ensure agency compliance and anticipate potential challenges.
Requirements:
- Minimum of a bachelor's degree and 5 years of experience in the preparation of complex deliverables under tight deadline constraints.
- At least three years of experience in Pharmaceutical Industry, Healthcare, or Advertising Agency.
- Familiarity with agency submission process and MLR preferred.
- Experience communicating with clients directly is required.
- Demonstrated knowledge of FDA pharmaceutical advertising regulations through appropriate training or previous experience is preferred.
- Strong attention to detail and ability to manage multiple submissions simultaneously in a fast-paced environment.
- Exceptional written and verbal communication skills, including technical writing, ensuring that all documentation and communication is clear and accurate.
- Ability to work both independently and collaboratively across departments to meet deadlines and maintain high standards of work.
- Strong organizational and problem-solving skills with a proactive approach to managing issues and challenges.
- Experience in Veeva Vault PromoMats.
What We Offer:
We offer a competitive salary band of $120,000 - $140,000, depending on qualifications and experience. Our team is passionate about delivering exceptional results and making a meaningful impact in the industry. If you are a motivated and detail-oriented professional with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.
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