Titan Laboratories Pvt. Ltd., a leading player in the API (Active Pharmaceutical Ingredient) division, is seeking a highly motivated and experienced Regulatory Affairs professional to join our dynamic team in Turbhe, Navi Mumbai. This is an exceptional opportunity to contribute significantly to the growth of a reputable organization and advance your career in a challenging and rewarding environment. If you are a detail-oriented individual with a proven track record in regulatory submissions and a passion for compliance, we encourage you to apply.

Job Overview:

We are searching for a skilled and experienced Regulatory Affairs Executive/Senior Executive to play a crucial role in our API division. The successful candidate will be responsible for the preparation, review, and submission of regulatory dossiers, managing queries, and ensuring compliance with global regulatory requirements. This position reports directly to the AGM – Regulatory Affairs.

Key Responsibilities:

This role demands a high level of attention to detail and a thorough understanding of global regulatory frameworks. Your responsibilities will include, but are not limited to:

• Dossier Preparation and Submission: Lead the preparation of comprehensive and compliant regulatory dossiers in ACTD/CTD format for various countries, including ROW (Rest of World) markets. This involves meticulous compilation and organization of technical data, ensuring adherence to specific regulatory guidelines and timelines.
• Dossier Review and Quality Assurance: Conduct thorough reviews of technical documents to ensure accuracy, completeness, and consistency with regulatory requirements. This includes identifying and resolving any discrepancies or inconsistencies.
• Regulatory Query Handling: Effectively manage and respond to queries from regulatory authorities in a timely and professional manner. This requires excellent communication skills and a deep understanding of regulatory expectations.
• License Management Support: Provide support in license-related activities, contributing to the maintenance and renewal of regulatory licenses and approvals.
• Staying Updated on Regulatory Changes: Remain informed about the latest regulatory changes and updates, ensuring compliance with evolving standards and guidelines. This includes actively monitoring changes in regulatory landscapes across different regions.
• Collaboration and Teamwork: Work collaboratively with internal teams, including research and development, quality control, and other relevant departments, to ensure efficient and effective regulatory submissions.

Desired Skills and Experience:

To excel in this role, you should possess the following:

• Extensive Regulatory Affairs Experience: A minimum of 4 to 7 years of experience in regulatory affairs within the pharmaceutical industry, with a proven track record of successful dossier preparation and submission.
• Technical Document Review Expertise: Demonstrated proficiency in reviewing and analyzing complex technical documents, ensuring accuracy and compliance.
• Regulatory Query Management: Exceptional skills in handling and resolving regulatory queries effectively and efficiently.
• ACTD/CTD Format Proficiency: Thorough understanding and practical experience in preparing and submitting dossiers in ACTD and CTD formats.
• Knowledge of International Regulations: Familiarity with regulatory requirements in various countries, including ROW markets.
• Excellent Communication Skills: Ability to communicate effectively both verbally and in writing, with strong interpersonal skills.
• Problem-Solving and Analytical Skills: Strong analytical and problem-solving abilities, with the capacity to identify and resolve regulatory issues proactively.
• Master’s Degree in Organic Chemistry: A Master of Science degree in Organic Chemistry or a closely related field is essential.

Application Process:

Interested and qualified candidates are encouraged to apply by sending their resume and cover letter to: shweta.m@titanpharma.com. Please mention “Regulatory Affairs Executive/Senior Executive” in the subject line of your email.

Location: Turbhe, Navi Mumbai, India

Notice Period: 1 Month

Number of Openings: 1

Reporting To: AGM – Regulatory Affairs

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