Senior Director of Regulatory Affairs

Job Title : Senior Director of Regulatory Affairs

Company : Augmentjobs

Salary Range : $160,000 - $270,000

Experience Level : 12 - 15 years

Job Description :

As the Senior Director of Regulatory Affairs at Augmentjobs, you will be a key leader in managing and overseeing all regulatory affairs activities within the company.

Your role will involve developing and implementing regulatory strategies to ensure compliance with all applicable laws and regulations while supporting the company'

s business goals. You will work closely with various departments, including R&D, manufacturing, and legal, to facilitate the successful approval and launch of new products and services.

Key Responsibilities :

Regulatory Strategy Development :

Develop and execute comprehensive regulatory strategies for new and existing products, ensuring alignment with corporate objectives and regulatory requirements.

Provide strategic guidance on regulatory issues to senior management and other key stakeholders.

Regulatory Compliance :

Oversee and ensure compliance with federal, state, and international regulations and standards relevant to the company'

s products and services.

Monitor changes in regulatory requirements and assess their impact on the company's operations.

Regulatory Submissions and Approvals :

Lead the preparation, submission, and management of regulatory documents, including new product applications, amendments, and renewals.

Coordinate with regulatory agencies to facilitate timely approvals and address any issues or queries.

Team Leadership and Development :

Build, lead, and mentor a high-performing regulatory affairs team.

Promote a culture of continuous improvement and professional development within the team.

Cross-Functional Collaboration :

Work closely with R&D, manufacturing, quality assurance, and legal teams to ensure regulatory considerations are integrated into product development and business processes.

Represent the regulatory affairs function in cross-functional project teams and strategy meetings.

Risk Management :

Identify and mitigate regulatory risks associated with the company's products and operations.

Develop and implement contingency plans to address potential regulatory challenges.

Stakeholder Engagement :

Establish and maintain strong relationships with regulatory agencies and industry groups.

Participate in industry forums and contribute to discussions on regulatory policies and practices.

Skills and Qualifications :

Education :

Bachelor's degree in Life Sciences, Engineering, or a related field (required).

Advanced degree (Master's or PhD) or professional certification (e.g., RAC) preferred.

Experience :

12-15 years of experience in regulatory affairs, with a significant portion in a leadership or senior management role.

Proven track record of managing regulatory submissions and interactions with regulatory agencies.

Technical Skills :

Deep understanding of regulatory requirements and guidelines in the relevant industry (e.g., pharmaceuticals, medical devices, biotechnology).

Strong knowledge of regulatory processes and standards in key markets, including the FDA, EMA, and other international regulatory bodies.

Leadership Skills :

Demonstrated ability to lead and develop a team, with strong coaching and mentoring skills.

Excellent strategic thinking and problem-solving abilities.

Communication Skills :

Exceptional written and verbal communication skills, with the ability to effectively present complex regulatory information to various audiences.

Proven ability to negotiate and influence outcomes with regulatory agencies and internal stakeholders.

Organizational Skills :

Strong project management skills with the ability to manage multiple priorities and deadlines.

Attention to detail and a commitment to high-quality work.

Working Conditions :

This role is based at Augmentjobs' headquarters with occasional travel required for meetings with regulatory agencies and industry events.

Flexibility in working hours may be necessary to accommodate international regulatory requirements and deadlines.

Application Process :

Interested candidates should submit their resume and a cover letter outlining their qualifications and experience relative to the job description.

This description provides a comprehensive overview of the Senior Director of Regulatory Affairs position, ensuring that candidates understand the responsibilities, skills, and qualifications required for the role.