- Develop and implement comprehensive regulatory strategies to ensure compliance with applicable laws and regulations.
- Oversee all aspects of regulatory submissions, including reviewing and editing submission documents, coordinating with cross-functional teams, and ensuring timely and accurate submission of all required documentation.
- Proactively engage and maintain effective communication with regulatory bodies, acting as the main point of contact for all regulatory inquiries and requests.
- Monitor regulatory changes and updates to ensure continuous compliance, and provide guidance and support to internal stakeholders on the interpretation and implementation of regulatory requirements.
- Collaborate with cross-functional teams, such as R&D, clinical affairs, quality assurance, and manufacturing, to develop and execute regulatory strategies that align with business goals and objectives.
- Participate in internal and external audits and inspections, as needed, and ensure compliance with all regulatory requirements.
- Stay current with industry trends and best practices in regulatory affairs to contribute to the development and enhancement of company-wide regulatory processes and procedures.
- Bachelor's degree in Law, Business, or a related field
- Demonstrated expertise in regulatory affairs within the pharmaceutical industry
- Thorough understanding of both local and international regulatory guidelines
- Strong knowledge of legal frameworks and compliance requirements in the pharmaceutical sector
- Proven experience in navigating complex regulatory environments and successfully obtaining product approvals
- Familiarity with relevant legislation, including FDA regulations and other regional regulatory bodies
- Ability to interpret and apply regulatory guidelines to ensure compliance throughout the drug development process
- Solid understanding of pharmacovigilance, risk management, and post-marketing surveillance
- Remote Work
- Permanent Position
- 30-Day Paid Leave
- 5-Day Work Week
- A competitive salary, reflective of your experience
- Health insurance coverage
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Head of Regulatory Affairs - Bakersfield, United States - Keller Executive Search
Description
We are seeking a proactive individual for the position of Head of Regulatory Affairs in Bakersfield, California. The successful candidate will play a vital role in ensuring the company's adherence to applicable laws and regulations. This position demands extensive knowledge of the regulatory landscape within the pharmaceutical industry. Key responsibilities include devising regulatory strategies, supervising regulatory submissions, and establishing effective communication channels with regulatory authorities.
To learn more about our executive recruitment and headhunting services in Bakersfield, California please see our page:
Responsibilities:
