Senior Regulatory Affairs Manager
Senior Regulatory Affairs Manager
Posted on :
25-06-2025
Employer Active
1 Vacancy
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Job Description
Responsibilities:
- Support the Senior Director in developing and executing regional regulatory strategies for QOL.
- initiatives within specific regions.
- Contribute to providing strategic oversight and leadership to the regulatory team ensuring alignment with company objectives and regional regulatory requirements.
- Participate in the preparation and submission of regulatory documents related to QOL initiatives to regulatory authorities.
- Collaborate with cross-functional teams to integrate QOL considerations into product development manufacturing and commercialization processes.
- Assist in fostering relationships with regional regulatory authorities to facilitate communication negotiations and interactions related to QOL initiatives.
- Stay informed about regulatory developments changes and trends within specific regions and provide insights to the Senior Director and Associate Director.
- Contribute to managing regulatory risks and opportunities related to QOL initiatives and assist in developing mitigation strategies as needed.
- Provide regulatory guidance and support for post-marketing activities related to QOL initiatives Including variations renewals labeling updates and compliance initiatives.
- Collaborate with the regulatory team to represent the companys interests in industry forums working groups and regulatory meetings related to QOL initiatives.
- Support coordination with global regulatory counterparts to ensure alignment of regional regulatory strategies and submissions with global development plans and corporate objectives.
- Assist in preparing regulatory updates progress reports and strategic recommendations for senior and/or executive leadership and regulatory governance committees.
- Assists in preparing and organizing all necessary documentation required for regulatory inspections and inspection readiness initiatives ensuring completeness accuracy and accessibility of records related to QOL initiatives.
- Participates in facilitating communication providing requested documentation and addressing any questions or concerns raised by the inspection readiness team in a timely and professional manner.
- Bachelors degree in scientific disciplines such as life sciences pharmacy bioscience; advanced degree preferred.
- 5 years of experience in regulatory affairs within the pharmaceutical or biotech industry with a preferred focus on quality-of-life products.
- Must have branded product reg affairs experience.
- Demonstrated ability to work effectively in a cross-functional team environment.
- Strong knowledge of regional regulatory requirements and guidelines including FDA regulations and ICH guidelines.
- Excellent communication and interpersonal skills.
- Ability to assist in developing and executing regulatory strategies tailored to specific regions.
- Strong organizational skills with attention to detail.
- Ability to collaborate effectively with cross-functional teams.
- Knowledge of regulatory submissions and documentation processes.
- Awareness of regulatory developments and trends within specific regions.
- Strong analytical and problem-solving skills.
- Ability to work independently and prioritize tasks effectively.
- Ability and willingness to travel approximately 10% of the year both domestically and internationally.
Employment Type
Full Time
Key Skills
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