Key Responsibilities:

Develop and maintain regulatory strategies for all products in accordance with local, regional, and international regulations.
Prepare and submit regulatory submissions, including but not limited to, INDs, NDAs, BLAs, and MAAs.
Manage the regulatory review process and address any deficiencies or questions from regulatory agencies.
Stay up-to-date with changes in regulations and guidelines and communicate any potential impact to the company.
Collaborate with cross-functional teams to ensure regulatory requirements are met for product development, manufacturing, labeling, and advertising.
Develop and maintain relationships with regulatory authorities to facilitate the review and approval process.
Conduct regulatory training for internal teams to ensure understanding and compliance with regulations.
Participate in regulatory agency meetings and negotiations as needed.

Qualifications:

Bachelor's degree in Life Sciences, Pharmacy, or related field. Advanced degree preferred.
A minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
Strong knowledge of FDA regulations and guidelines. Knowledge of international regulations is a plus.
Experience in preparing and submitting regulatory submissions.
Excellent communication and interpersonal skills.
Ability to work effectively in a fast-paced, dynamic environment.
Strong attention to detail and ability to manage multiple projects simultaneously.
Demonstrated ability to collaborate with cross-functional teams and external stakeholders.

Join our team and help us bring life-changing products to patients in need.

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