Our company is a leading global player in the pharmaceutical industry, focused on enhancing patient outcomes through innovative solutions. With a strong commitment to quality, safety, and efficacy, we are dedicated to developing, manufacturing, and marketing medicines that address a wide range of health needs. Headquartered in India, we are currently looking to expand our team and invite passionate individuals to apply for the position of Team Member – Regulatory Writing based in Vikhroli, Maharashtra.

Responsibilities in the Job

As a Team Member – Regulatory Writing, you will be a key player in supporting the Regulatory Affairs (RA) team by preparing crucial medical writing documents for dossier filings and renewals. Your responsibilities will include:

1. Preparation of Regulatory Documents: You will prepare medical writing documents that support global product registration and lifecycle management, excluding India.
2. Providing Regulatory Insights: You will assist the RA team by offering insights into European, WHO, MCC, and US regulatory strategies. This includes helping with biowaivers, posology, and proposed indications by comparing country-specific product information and guidelines.
3. Responding to Regulatory Queries: You’ll be responsible for preparing documents as responses to global regulatory/customer queries on submitted dossiers. This includes addressing scientific justifications, bio-waiver justifications, and regulatory strategy documents.
4. Cross-Functional Coordination: Collaborating with various departments such as Business Development (BD), packaging, Regulatory Affairs (RA), Pharmacovigilance (PV), and others, you will work towards reducing query cycle times and enhancing document quality.

Qualifications

To be considered for this position, candidates should meet the following qualifications:

• Educational Qualification: A Bachelor’s or Master’s degree in Pharmacy.
• Relevant Work Experience: 1-4 years of experience in regulatory medical writing or a similar field.

Skills Required

The ideal candidate will possess the following competencies and skills:

• Collaboration: Strong ability to work with cross-functional teams to achieve common goals.
• Innovation: A mindset focused on continuous improvement and creativity in regulatory writing.
• Accountability: High attention to detail and commitment to delivering quality work within deadlines.
• Empathy: Ability to lead with empathy and support team members effectively.
• Agility: Flexibility in adapting to changing regulatory requirements and processes.
• Domain Knowledge: Strong knowledge of regulatory medical writing and global regulatory processes.
• People Management: Ability to collaborate effectively and manage cross-functional relationships.

Application Link