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1 Adcock Ingram Job

Regulatory Affairs

5-8 years

Bangalore / Bengaluru

3 vacancies

Regulatory Affairs

Adcock Ingram

posted 9d ago

Job Role Insights

Fixed timing

Job Description

We are seeking a qualified and experienced Senior Officer/Executive to join our Regulatory Affairs Team. The ideal candidate will specialize in preparing, compiling, and reviewing regulatory dossiers in compliance with international standards and regulatory authority requirements, with a focus on South Africa and other country-specific markets.


❖ Roles & Responsibilities:

Dossier Preparation and Review:

Compile and review high-quality CTD dossiers and variations as per South Africa and other country-specific requirements, including electronic dossier (dB) compilation and publishing.

Prepare high-quality eCTD dossiers for new submissions, variations, and responses tailored to regulatory requirements.

Agency Communication and Submission:

Develop and submit quality responses to agency queries within specified timelines.

Collaborate with South African counterparts and principals to validate and electronically publish regulatory documents.

Documentation and Compliance:

Review and manage scientific and technical documents, including DMFs, CEPs, and drug product-related documents, ensuring adherence to regulatory requirements.

Prepare, update, and review product labeling and information.

Cross-functional Collaboration:

Coordinate with RD&I, manufacturing sites, customers, and principals to gather required documents for dossier compilation.

Manage notifications and documentation for implementation of amendments.

Regulatory Process Management:

Ensure documentation practices align with organizational and regulatory standards.

Maintain organized and accurate records for all regulatory activities.Role & responsibilities


❖ Requirements:

Bachelors or Master’s degree in Pharmacy (B. Pharm or M. Pharm).

Proven experience in regulatory affairs, with a specialization in dossier preparation for South Africa or similar markets.

Proficiency in electronic publishing tools and CTD/eCTD dossier formats.

In-depth understanding of South Africa-specific regulatory guidelines.

Strong organizational, communication, and documentation skills.

Ability to prioritize multiple projects and meet strict deadlines.

Collaborative team player with a proactive and detail-oriented mindset.




Employment Type: Full Time, Permanent

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What people at Adcock Ingram are saying

What Adcock Ingram employees are saying about work life

based on 163 employees
60%
71%
57%
95%
Strict timing
Monday to Saturday
No travel
Day Shift
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Adcock Ingram Benefits

Job Training
Health Insurance
Cafeteria
Free Food
Soft Skill Training
Team Outings +6 more
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Regulatory Affairs

5-8 Yrs

Bangalore / Bengaluru

9d ago·via naukri.com

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