Assistant Manager / Deputy Manager - Regulatory Affairs (Api)

10-15 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: Assistant Manager / Deputy Manager - Regulatory Affairs (API)

Location: Balanagar, Hyderabad, Telangana, India
Department: Regulatory Affairs
Job Posted On: Feb 12, 2025
Employee Type: Permanent
Experience Range: 10 years - 15 years

Key Responsibilities:

1. DMF Preparation and Compilation:

Responsible for the preparation and compilation of Drug Master Files (DMFs) in compliance with regulations of Regulatory and Semi-Regulatory countries.
Ensure that all DMFs align with the required regulatory standards for different markets.

2. Coordination with Marketing Teams:

Provide support to the concerned Marketing department/team by providing the necessary documentation required for product registrations and regulatory submissions.
Collaborate effectively with marketing teams, customers, and plants to address any regulatory-related queries.

3. Cross-Functional Coordination:

Work closely with cross-functional teams such as Quality Control (QC), Quality Assurance (QA), Research and Development (R&D), and Production to gather the required documents for compiling the API DMFs.
Ensure smooth collaboration and communication among teams to meet submission deadlines.

4. Development of DMFs for Global Markets:

Develop DMFs for product registrations in international markets including Brazil, China, and Russia.
Tailor DMF content to meet the regulatory requirements of different countries.

5. Scientific Data Evaluation:

Collect, collate, and evaluate scientific data received from R&D or plant operations for inclusion in regulatory submissions and ensure compliance with applicable standards.

6. Planning, Coordination, and Submission of DMFs:

Responsible for the timely planning and coordination of the submission of API DMFs and handling any deficiencies in markets, especially EMT (Emerging Markets and Territories).
Ensure the completeness and accuracy of documents before submission to regulatory authorities.

7. Document Review and Gap Identification:

Conduct review of documents and ensure their suitability for regulatory submission.
Identify any gaps in the documentation, and take corrective actions to ensure compliance with the regulatory requirements of the targeted markets.

8. Guidance on EMT Regulatory Strategy:

Provide guidance to cross-functional teams and team members regarding EMT regulatory strategy and the specific regulatory requirements of different regions.
Support regulatory strategy and provide insights to optimize the product lifecycle management process.

9. Technical Queries and Customer Response:

Respond timely and effectively to external customers with technical queries and requests related to regulatory submissions, ensuring clear communication of requirements and compliance updates.

10. Life Cycle Management of Products:

Oversee the life cycle management of products from a regulatory perspective, ensuring that necessary regulatory activities (e.g., post-market compliance) are conducted throughout the product’s lifecycle.
Support ongoing regulatory activities for product maintenance and updates as required.

11. Compliance with Regulatory Requirements:

Ensure strict adherence to regulatory requirements in all stages of API development, documentation, submission, and life cycle management.
Regularly update internal teams on the evolving regulatory landscape and ensure company compliance with international standards.

Qualifications and Skills:

Education:

Master's degree or Bachelor's degree in Pharmacy, Chemical Engineering, or a related scientific field.

Experience:

10 to 15 years of experience in Regulatory Affairs, with a strong focus on API (Active Pharmaceutical Ingredients).
Hands-on experience with DMF preparation and submissions for API registration in international markets.
Expertise in regulatory requirements for Brazil, China, Russia, and other Emerging Markets.

Technical Skills:

In-depth understanding of API regulatory guidelines, including EMT market regulations and global regulatory standards.
Proficient in regulatory documentation management and the submission process for drug registrations.
Experience working with cross-functional teams in regulatory affairs, quality, production, and R&D.

Soft Skills:

Strong communication and interpersonal skills to coordinate effectively with global teams and external stakeholders.
Excellent attention to detail with the ability to identify regulatory gaps and resolve issues.
Strong project management and organizational skills to manage multiple submissions and regulatory activities simultaneously.

Work Environment:

Office-based role at the company’s facilities in Balanagar, Hyderabad, requiring regular collaboration with cross-functional teams and external clients.
The position may require occasional travel for meetings, audits, and inspections as part of the regulatory processes.

Key Performance Indicators (KPIs):

Timeliness and accuracy of DMF submissions.
Effective coordination and collaboration with internal and external teams.
Compliance with global regulatory requirements during the product lifecycle.
Quality and timeliness of responses to customer queries.

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Assistant Manager / Deputy Manager - Regulatory Affairs (Api)

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