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30 Arco Lab Jobs
Sr.Team Team Leader - Regulatory Affairs, Emerging Market
10-14 years
Bangalore / Bengaluru
1 vacancy
Sr.Team Team Leader - Regulatory Affairs, Emerging Market
Arco Lab
posted 3hr ago
Job Description
- Regulatory Strategy Development:
- Develop and execute regulatory strategies for launching products in Emerging markets (SEA, GCC, CIS & Latam), considering regional nuances and regulatory requirements.
- Stay updated on regulatory changes and assess their impact on product registrations and compliance strategies.
- Regulatory Submissions and Approvals:
- Lead the preparation, submission, and management of regulatory dossiers and applications to obtain timely approvals for product launches.
- Coordinate responses to regulatory queries and requests for additional information to expedite approval processes.
- Cross-functional Collaboration:
- Collaborate closely with internal and external stakeholders such as R&D, Quality Assurance, Legal, and Marketing to ensure regulatory requirements are integrated into product development and launch plans.
- Provide regulatory guidance and support to teams to resolve issues and mitigate risks.
- Compliance and Risk Management:
- Monitor regulatory compliance throughout the product lifecycle, including post-market surveillance and reporting obligations.
- Assess regulatory risks and develop mitigation strategies to ensure business continuity and compliance with regulations.
- Relationship Management:
- Establish and nurture strong relationships with regulatory authorities and agencies and customers in Emerging Markets.
- Represent the organization in regulatory meetings, negotiations, and discussions to influence regulatory outcomes beneficial to the company.
- Regulatory Intelligence and Training:
- Stay abreast of emerging trends, guidelines, and best practices in regulatory affairs relevant to Emerging Markets.
- Conduct training sessions for internal teams to enhance awareness and understanding of regulatory requirements and processes.
Employment Type: Full Time, Permanent
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