Regulatory Affairs (Api)-Assistant Manager

6-10 years

Not Disclosed

Hyderabad India

10 Feb. 18, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs (API)-Assistant Manager

Location: Balanagar, Hyderabad, Telangana, India
Department: Regulatory Affairs
Job Posted On: Feb 17, 2025
Employee Type: Permanent
Experience Range: 6-10 years

Roles & Responsibilities:

1. Preparation and Compilation of DMFs:

The Assistant Manager will be responsible for preparing and compiling DMFs (Drug Master Files) in compliance with the regulations of both Regulatory and Semi-Regulatory countries.
This includes understanding the regulatory requirements for markets such as Brazil, China, and Russia, and ensuring that the DMFs align with country-specific standards.
The role requires attention to detail and knowledge of the regulatory frameworks governing the submission of APIs (Active Pharmaceutical Ingredients) in these regions.

2. Coordination with Cross-Functional Teams:

The position involves close collaboration with various internal departments, such as Marketing, QC (Quality Control), QA (Quality Assurance), R&D, and Production teams.
The Assistant Manager will be responsible for procurement of necessary documents and facilitating the development of documentation required for compiling the API DMFs. This requires excellent coordination and organizational skills to manage the flow of information across teams.

3. Communication with External Stakeholders:

The Assistant Manager will attend calls and meetings with marketing teams, customers, and plants as needed, to discuss regulatory matters, resolve issues, and provide updates on the progress of DMF submissions.
This requires strong interpersonal skills to maintain effective communication with internal stakeholders, as well as external customers and regulatory bodies.

4. Development of DMFs for Global Markets:

One of the key responsibilities is the development and submission of DMFs for product registration in international markets like Brazil, China, and Russia.
The Assistant Manager will be responsible for collecting and evaluating scientific data from various sources, including R&D and plant departments, and ensuring that it is compiled into regulatory-compliant documents.

5. Timely Planning, Coordination, and Submission of DMFs:

The role involves timely planning, coordination, and submission of DMFs and addressing any deficiencies that arise in markets requiring EMT (Emerging Markets and Territories) submissions.
The Assistant Manager must ensure that these submissions meet the required deadlines while maintaining high-quality standards.

6. Review of Documents and Identification of Gaps:

The candidate will be tasked with reviewing documents for accuracy, completeness, and regulatory compliance.
A critical aspect of this role is to identify any gaps in the documents and ensure they are addressed before submission. The Assistant Manager will ensure that all documents are suitable for regulatory acceptance.

7. Guidance on EMT Regulatory Strategy:

As a subject matter expert, the Assistant Manager will provide guidance to cross-functional teams on the EMT regulatory strategy and regional regulatory requirements.
This includes advising on how to navigate the regulatory landscape in different markets and ensuring the successful submission and approval of products.

8. Technical Query Management:

The Assistant Manager will be responsible for providing timely, quality responses to external customers regarding technical queries and requests related to the DMF process.
This will involve working closely with regulatory bodies, answering detailed questions about the API DMF documents, and ensuring that customer requirements are met.

9. Life Cycle Management of Products:

Another essential aspect of the role is overseeing the life cycle management of products. This includes managing ongoing regulatory submissions, updates, and amendments as required for product maintenance in different markets.
The Assistant Manager will ensure that all products remain compliant throughout their life cycle and assist in resolving any issues that may arise during this time.

10. Compliance Maintenance:

Maintaining compliance with the regulatory requirements is a fundamental aspect of the Assistant Manager’s responsibilities.
The Assistant Manager will be tasked with ensuring that all regulatory processes and submissions are in line with current laws and industry best practices.

Qualifications:

Educational Requirements:
- M.Pharma, B.Pharma, or M.Sc. (Chemistry) or any equivalent qualification in a related field.
Experience:
- A minimum of 6-10 years of experience in Regulatory Affairs with a focus on API submissions, preferably in the EMT markets.
- In-depth experience in DMF preparation and compilation for various international markets (e.g., Brazil, China, Russia).
Skills & Competencies:
- Strong knowledge of global regulatory frameworks governing API submissions, particularly in emerging markets.
- Excellent communication skills to coordinate with internal teams and interact with external stakeholders.
- Ability to analyze, review, and compile documents in accordance with regulatory requirements.
- Strong organizational skills and the ability to handle multiple projects simultaneously.
- Problem-solving skills to address issues that arise during the regulatory submission process.
- Proficiency in MS Office applications for document preparation and coordination.

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Regulatory Affairs (Api)-Assistant Manager

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