Sr. Regulatory Affairs Manager

Katalyst CRO; Boulder (CO); On-site; USD 100,000 - 130,000; Part time

Job summary

A prominent life sciences company is looking for a Sr. Regulatory Affairs Manager to support the development of regulatory strategies and ensure compliance with regulatory requirements. The role involves preparing regulatory submissions and collaborating with cross-functional teams. Ideal candidates will have a Bachelor's degree and at least 5 years of experience in regulatory affairs, specifically with branded products, and a strong understanding of FDA regulations. Competitive compensation and a supportive work environment are offered.

Qualifications

• 5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry.
• Experience with branded product regulatory affairs.
• Knowledge of FDA regulations and ICH guidelines.

Responsibilities

• Support the Senior Director in developing regulatory strategies.
• Prepare and submit regulatory documents related to QOL initiatives.
• Foster relationships with regional regulatory authorities.

Skills

Effective teamwork

Communication skills

Regulatory knowledge

Analytical skills

Organizational skills

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Job description

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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 company's 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.
• Assist 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.
• Participate in facilitating communication, providing requested documentation, and addressing any questions or concerns raised by the inspection readiness team in a timely and professional manner.

Requirements

• Bachelor's degree in a scientific discipline such as life sciences, pharmacy, bioscience; advanced degree preferred.
• 5+ years of experience in regulatory affairs within the pharmaceutical or biotech industry, with a focus on quality‑of‑life products preferred.
• Must have branded product regulatory 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.

Seniority Level

• Mid-Senior level

Employment Type

• Contract

Job Function

• Legal

Industries

• Pharmaceutical Manufacturing