Drug Regulatory Affairs Executive

Job content

Lucent Biotech Limited company Hiring For Drug Regulatory Affairs Executive .

Regulatory affairs officers ensure the appropriate licensing, marketing and legal compliance of a range of pharmaceutical and medical products in order to control their safety and efficacy

As a regulatory affairs officer you’ll be the crucial link between your company, its products and regulatory authorities. You’ll combine your knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a range of companies, meet the required legislation.

Products include:

• pharmaceuticals

.

Responsibilities

As a regulatory affairs officer, you’ll need to:

• ensure that a company’s products comply with the regulations of the regions where they want to distribute them
• keep up to date with national and international legislation, guidelines and customer practices
• collect, collate and evaluate scientific data from a range of sources
• develop and write clear arguments and explanations for new product licences and licence renewals
• prepare submissions of licence variations and renewals to strict deadlines
• monitor and set timelines for licence variations and renewal approvals
• work with specialist computer software and resources
• write clear, accessible product labels and patient information leaflets
• plan and develop product trials and interpret trial data
• advise scientists and manufacturers on regulatory requirements
• provide strategic advice to senior management throughout the development of a new product
• project manage teams of colleagues involved with the development of new products
• undertake and manage regulatory inspections
• review company practices and provide advice on changes to systems
• liaise with, and make presentations to, regulatory authorities
• negotiate with regulatory authorities for marketing authorisation
• take part in the development of marketing concepts and approve packaging and advertising before a product’s release.

Salary

• Salaries for specialist or experienced regulatory affairs professionals (three to five years’ experience) typically range from Rs. 20000 to Rs.30,000 per month
• Qualifications

You’ll usually need at least a good honours degree to work as a regulatory affairs officer. Relevant degree areas include life, physical, mathematical, applied and medical sciences. In particular, the following subjects may increase your chances:

• biochemistry
• biology
• biomedical engineering
• biomedical science
• biotechnology
• chemical and physical sciences
• chemistry
• medicine
• pharmacology
• pharmacy.

It’s also possible to take a four-year, full-time Master of Regulatory Science (Pharmaceutical and Devices) .

Skills

You’ll need to have:

• understanding of both legal and scientific matters
• the ability to grasp new concepts quickly and to assimilate and evaluate scientific data
• analytical and problem-solving skills
• written and oral communication skills
• attention to detail
• strong negotiation skills
• IT skills, particularly in relation to using databases and familiarity with commercial software
• the ability to work under pressure and to strict deadlines
• the confidence to report to management
• teamworking skills and the ability to lead and motivate others
• project-management skills
• manufacturing techniques
• relevant aspects of the law.

Contact Person: Chandni Rai

( Hr Manager)

Contact no. : 6307854992

Job Type: Full-time

Pay: ₹20,000.00 - ₹30,000.00 per month

Benefits:

• Health insurance

Schedule:

• Day shift

Ability to commute/relocate:

• near Yojana bhawan, Lucknow - 226001, Uttar Pradesh: Reliably commute or planning to relocate before starting work (Required)

Experience:

• 5 yeras: 3 years (Preferred)