We are looking for a highly knowledgeable Regulatory Affairs Pharmacist to join our team. This role is critical in ensuring that our pharmaceutical products comply with all regulations and standards set by regulatory bodies. The ideal candidate will have a strong background in regulatory affairs, a keen attention to detail, and excellent communication skills to effectively liaise with regulatory agencies and internal teams.
Key Responsibilities:
Ensure compliance with all regulatory requirements for the development, manufacturing, and marketing of pharmaceutical products.
Prepare, review, and submit regulatory documentation, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Abbreviated New Drug Applications (ANDA).
Maintain up-to-date knowledge of regulatory guidelines and changes, including FDA, EMA, and other global regulatory bodies.
Provide regulatory guidance to cross-functional teams, including R&D, clinical, and quality assurance departments.
Coordinate and communicate with regulatory agencies to facilitate timely approvals and resolve any issues or queries.
Develop and implement regulatory strategies to expedite the approval of new products and maintain compliance of existing products.
Review product labeling, advertising, and promotional materials for regulatory compliance.
Conduct internal audits and support external regulatory inspections and audits.
Ensure accurate and timely reporting of adverse drug reactions and other pharmacovigilance activities.
Participate in the development and training of regulatory policies and procedures within the organization.
Preferred Qualifications:
Bachelor's of Pharmacy or PharmD degree from an accredited pharmacy program.
Experience in regulatory affairs within the pharmaceutical industry.
State pharmacy license in good standing.
Proficiency in preparing and submitting regulatory documents.
Strong analytical and problem-solving skills.
Excellent communication and collaboration abilities.
Familiarity with electronic submission systems and regulatory databases.
Certification in regulatory affairs (e.g., RAC) preferred.
Dedication to ongoing professional development and continuous improvement.
If you are an experienced Regulatory Affairs Pharmacist looking to play a key role in ensuring compliance and facilitating the successful approval of pharmaceutical products, we invite you to join our team. Apply now to contribute to a collaborative and regulatory-focused healthcare environment.
...Overview & Key Responsibilities) Join Delta Air Lines as a Flight Attendant At Delta Air Lines, connection is at the heart of... ...during their travels with us and aim to deliver an elevated experience. With service to over 290 destinations on six continents,...
...Requirements: Must be a U.S. citizen. Communicative, coachable, and reliable. Remote work discipline and organizational skills. Benefits Benefits: Work from anywhere. Flexible hours with uncapped earning potential. Professional mentorship included....
...Rantec Power Systems Inc. is hiring Interns at $21.00/hr! Starting Summer 2025. Come... ...and aerospace markets. We are an engineering-based company, with expertise in all aspects... ...and Experience Pursuing a degree in Mechanical/Aerospace Engineering SolidWorks...
The Offer Great work culture Role involving team management opportunities Flexible working options The Job Position Overview: As a Remote Data Entry Clerk at Meati, your primary responsibility will be to accurately and efficiently input data into our ...
...dynamic Risk Advisory group, in Boca Raton. This group assists broker-dealers, registered investment advisors, and hedge fund... ...execution and completion of operational, regulatory compliance, and business process control assessments Perform evaluation and testing...