Here’s a rewritten version of your job description, ensuring originality while maintaining clarity and professionalism:
Regulatory Affairs Manager
Role Overview:
The Regulatory Affairs Manager plays a critical role in supporting the regulatory department to ensure compliance and efficiency in business operations. This position involves executing regulatory responsibilities, collaborating across multiple business functions, and providing expert consultation. Key duties include identifying and obtaining required data, ensuring its proper presentation for product registration, and conducting regulatory assessments using global data. The role also involves preparing and submitting necessary documentation for regulatory approvals in India and international markets while offering technical leadership to various business units.
Key Responsibilities:
- Ensure compliance with corporate and divisional policies, regulatory procedures, and industry standards.
- Assist in developing, reviewing, and updating Standard Operating Procedures (SOPs) related to regulatory affairs.
- Provide regulatory guidance throughout the product lifecycle and contribute to strategic planning.
- Monitor regulatory changes and update strategies accordingly.
- Interpret and apply relevant regulatory requirements while assessing potential impacts on product approvals and claims.
- Stay informed about internal and external industry trends and regulatory developments to anticipate challenges.
- Participate in risk-benefit analyses for regulatory compliance.
- Manage and oversee a variety of regulatory projects, ensuring timely completion of milestones.
- Depending on the role's specific focus, responsibilities may include reviewing clinical documentation, handling regulatory submissions and follow-ups, evaluating manufacturing changes for regulatory impact, maintaining licenses and registrations, overseeing advertising and labeling compliance, and contributing to product safety reviews and recall processes.
Leadership & Influence:
- Provide guidance and mentorship to junior or less-experienced team members.
- Assist in training initiatives by sharing regulatory knowledge and expertise.
- Collaborate with management across different departments, often coordinating cross-functional efforts.
- Operate independently with minimal supervision, making informed regulatory decisions.
Qualifications & Experience:
- A degree in a science-related field such as nutrition, dietetics, biology, chemistry, pharmacy, pharmacology, microbiology, or medical technology.
- Additional qualifications in business management are highly desirable.
- Strong knowledge of regulatory frameworks, including FSSAI and other food and drug regulatory authorities.
- 8-10 years of experience in regulatory affairs, with consideration for backgrounds in quality assurance, R&D, or scientific affairs.
- At least 3-4 years of experience in a regulated industry, such as pharmaceuticals, medical products, or nutritionals.
Required Regulatory Expertise:
- In-depth understanding of regulatory guidelines, policies, agency structures, and ethical considerations.
- Familiarity with Good Practices (GxPs), including GMP, GLP, and GCP.
- Knowledge of promotion, advertising, and labeling requirements.
- Expertise in food and pharmaceutical regulations, particularly within India and Asia, is an advantage.
Skills & Competencies:
- Strong verbal and written communication skills, with the ability to engage diverse audiences.
- Ability to collaborate and negotiate with professionals from different disciplines and cultural backgrounds.
- Analytical thinking and problem-solving skills for evaluating regulatory strategies and scientific data.
- Keen attention to detail and the ability to manage multiple projects and timelines.
- Proficiency in using computer applications and regulatory tools.
Accountability & Scope:
- Lead and oversee technical and scientific regulatory functions independently.
- Make informed decisions on regulatory matters while ensuring compliance with deadlines.
- Effectively communicate and negotiate with internal stakeholders and regulatory agencies.
- Take charge of cross-functional regulatory projects, driving them to successful completion.
Apply Now:
To explore this opportunity, submit your application through the following link: Apply Here