Role Objective:
The Senior Executive - Regulatory Affairs will be responsible for ensuring that the company's products meet all regulatory requirements across various markets. This role involves preparing and reviewing product dossiers, handling document legalization, responding to regulatory queries, and training new employees on regulatory processes. The objective is to ensure timely and accurate submissions, maintain compliance with country-specific guidelines, and support the company's regulatory strategy.
Desired Candidate Profile:
- Education: Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
- Experience: Minimum of 5-7 years of experience in regulatory affairs within the biotech or pharmaceutical industry.
- Skills: Excellent knowledge of regulatory guidelines, strong analytical and problem-solving skills, attention to detail, and effective communication abilities.
- Attributes: Ability to work under pressure, manage multiple priorities, and collaborate effectively with cross-functional teams.
Role & Responsibilities:
Document Screening and Analysis:
- Screen documents as per registration requests received for respective products.
- Analyse and verify document requirements against country-specific guidelines.
- Communicate document requirements to project team members.
Dossier Preparation and Submission:
- Prepare, compile, and review product dossiers as per customer requirements.
- Ensure dossiers are prioritized and submitted within defined timelines.
- Handle dossier submission to various countries and ensure timely customer submissions.
Document Legalization and Coordination:
- Manage legalization or Apostillation of registration documents.
- Coordinate with agencies to receive attested documents and clear invoices.
Employee Training:
- Train new employees on product awareness and dossier preparation as per country-specific registration guidelines.
Query Management:
- Review and respond to regulatory queries with appropriate documentation and justification.
- Coordinate with team members to prepare query compliance-related documents.
Supportive Document Arrangement:
- Arrange batch-related documents, DOC, and COA for registration samples as required.
Document Management:
- Regularly update supporting documents and records of product TMFs.
- Ensure technical content consistency across similar product categories.
Technical Document Support:
- Provide support for updating technical documents like Clinical Evaluation Reports, Risk Management Reports, and GSPRs.
Post Market Surveillance (PMS):
- Support the periodic update of Post Market Surveillance (PMS) Reports for all products.
Functional Skills Required:
- In-depth knowledge of regulatory guidelines and requirements.
- Proficiency in document preparation and submission processes.
- Experience with dossier preparation and regulatory query management.
- Strong analytical skills for document screening and requirement analysis.
Behavioural Skills Required:
- Excellent communication and interpersonal skills.
- High attention to detail and organizational abilities.
- Ability to work independently and as part of a team.
- Capability to manage multiple projects and meet deadlines.
- Strong problem-solving skills and adaptability to changing regulatory environments.
Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground including gender, race, religion, age, sexual orientation, disability, etc.
