Manager Regulatory Affairs

JOB DESCRIPTION:

Job Summary:  The successful candidate will be responsible for developing and implementing regulatory strategies for new products, managing the life cycle of existing products, conducting SEC meetings, and drafting critical responses to new product queries and legal matters.

Key Responsibilities:

Develop and implement overall regulatory strategy for new products.

Manage the life cycle of existing products, ensuring compliance with regulatory requirements.

Conduct SEC meetings and ensure all regulatory submissions are accurate and timely.

Draft critical responses to new product queries and legal matters.

Collaborate with cross-functional teams to ensure regulatory compliance and support product development.

Monitor changes in regulatory requirements related New products and communicate their impact on the company’s products and processes.

Provide regulatory guidance and support to internal teams and stakeholders.

Qualifications:

Bachelor's / Masters degree in Regulatory Affairs, Life Sciences, or related field. Advanced degree preferred.

Minimum 10-12 years of experience in regulatory affairs

Strong knowledge of regulatory requirements and guidelines.

Excellent communication and interpersonal skills.

Ability to manage multiple projects and deadlines.

Detail-oriented with strong analytical and problem-solving skills.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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