Regulatory Affairs Specialist

Regulatory Affairs Specialist
A Global Pharmaceutical Company are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team. The successful candidate will play a key role in ensuring compliance with regulatory requirements for the development, registration, and commercialization of pharmaceutical products. This position offers an exciting opportunity to contribute to the success of our Regulatory Affairs initiatives and support our mission of delivering high-quality healthcare solutions to patients.
Location - Please note that this is a fully remote position.
Responsibilities:

1. Regulatory Submissions:

Prepare, review, and submit regulatory documents, including but not limited to, INDs, NDAs, BLAs, DMFs, and variations, ensuring compliance with applicable regulations and guidelines.

Coordinate with cross-functional teams to compile necessary documentation for regulatory submissions in a timely manner.

Regulatory Compliance:

Monitor regulatory requirements and guidelines to ensure compliance with evolving regulations and standards.

Provide regulatory guidance and support to internal stakeholders on matters related to product development, labeling, advertising, and promotional activities.

Regulatory Strategy:

Develop and implement regulatory strategies for assigned projects, collaborating with internal teams to achieve regulatory milestones and objectives.

Conduct regulatory assessments and risk analyses to identify potential regulatory challenges and opportunities.

Regulatory Intelligence:

Monitor and analyze regulatory trends, changes, and developments affecting the pharmaceutical industry, and communicate relevant updates to internal stakeholders.

Participate in industry forums, workshops, and conferences to stay informed about regulatory best practices and emerging requirements.

Regulatory Documentation:

Maintain accurate and up-to-date regulatory documentation, records, and databases.

Ensure completeness and accuracy of regulatory submissions and correspondence with regulatory agencies.

Quality Assurance:

Support quality assurance activities related to regulatory compliance, including internal audits, inspections, and corrective actions.

Qualifications:

Bachelor's degree in pharmacy, life sciences, or a related field; advanced degree preferred.

Minimum of 3 years of experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.

Working knowledge of US and international regulatory requirements, including FDA regulations, ICH guidelines, and other relevant regulations.

Strong understanding of drug development processes, including preclinical, clinical, and post-marketing phases.

Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory concepts to diverse audiences.

Proven ability to work collaboratively in a cross-functional team environment and manage multiple priorities with a high level of attention to detail.

Proficiency in regulatory software applications and document management systems.

Benefits:

Competitive salary and benefits package.

Opportunities for professional development and career advancement.

Flexible work arrangements.

Comprehensive healthcare coverage.

Retirement savings plan.

Employee assistance program.

Join us in our mission to improve patient outcomes through regulatory excellence. If you are passionate about Regulatory Affairs and seek a rewarding career in a dynamic pharmaceutical environment, we encourage you to apply.