PharmaLex is Hiring for Specialist/Senior Specialist in Regulatory Affairs
PharmaLex, a leading regulatory affairs service provider, is currently seeking qualified candidates for the role of Specialist/Senior Specialist to join their Regulatory Affairs team. If you have a background in pharmacy and a keen interest in regulatory compliance within the pharmaceutical industry, this could be an excellent opportunity for you.
Regulatory affairs play a crucial role in ensuring that pharmaceutical products meet the necessary standards and comply with regulatory requirements. PharmaLex, with its extensive expertise and global presence, provides comprehensive regulatory solutions to pharmaceutical companies worldwide. In this article, we will explore the job opportunity available at PharmaLex and provide insights into the role and application process.
Overview of PharmaLex
PharmaLex is a renowned regulatory affairs service provider known for its commitment to excellence and client satisfaction. With offices located globally, PharmaLex offers a wide range of services, including regulatory strategy, submission support, pharmacovigilance, and quality management. PharmaLex’s team of experts works closely with clients to navigate complex regulatory frameworks and ensure compliance with international standards.
Job Opportunity in Regulatory Affairs
Role and Responsibilities
The Specialist/Senior Specialist role in Regulatory Affairs at PharmaLex entails a range of responsibilities related to documentation and compliance. Some of the key activities include handling of CCDS (Company Core Data Sheet) related documents, such as core documents for Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL), justification documents, change history, and local deviation forms. The role also involves archiving relevant communication and documents, handling labelling documents in Document Management Systems (DMSs), and drafting comparisons between CCDS and local labeling requirements.
Location and Work Model
The job opportunities are available in two locations: Noida and Mumbai. PharmaLex follows a hybrid work model, providing flexibility in terms of both remote and office-based work arrangements. This model allows employees to maintain a healthy work-life balance while collaborating effectively with colleagues and clients.
Qualifications and Experience
Candidates applying for the Specialist/Senior Specialist role in Regulatory Affairs should hold an M.Pharm or B.Pharm degree. Additionally, they should have 2 to 3 years of relevant experience in regulatory affairs, particularly in handling documentation related to CCDS and local labeling. Proficiency in regulatory guidelines and a strong attention to detail are essential for this role.
If you meet the qualifications and have the necessary experience, you can apply for the Specialist/Senior Specialist role by reaching out to Aditi Panchal via email at email@example.com. Please include your updated resume and any additional information that highlights your relevant experience and skills. The HR team at PharmaLex will review your application and contact you if you are shortlisted for further consideration.
Benefits of Working at PharmaLex
Joining PharmaLex offers numerous advantages for professionals in the regulatory affairs field. As part of the PharmaLex team, you will have the opportunity to work with industry experts, expand your knowledge of regulatory compliance, and gain exposure to diverse projects. PharmaLex values its employees and provides a supportive work environment that encourages professional growth and development. Additionally, the company offers competitive compensation packages and benefits, reflecting its commitment to employee well-being and satisfaction.