Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Affairs - Permanent - Parsippany (Remote)

Are you a regulatory affairs professional passionate about making a difference in people's lives? Do you thrive in dynamic environments where your expertise can shape global strategies? If so, this is your opportunity to be part of something impactful!

We are seeking a Senior Manager, Regulatory Affairs to play a key role in advancing our mission to deliver innovative healthcare solutions. In this pivotal position, you'll collaborate with cross-functional teams and regulatory authorities, ensuring compliance and excellence across all initiatives.

Primary Responsibilities:

The successful candidate is someone who thrives in a dynamic environment, possesses excellent communication skills, and has a proven track record in regulatory affairs. You will be responsible for leading regulatory submissions, managing regulatory timelines, and ensuring that all activities comply with relevant regulations and guidelines.

What We're Looking For:

• Qualifications: Bachelor's degree in life sciences, pharmacy, or a related field; an advanced degree is preferred.
• Experience: 5+ years in regulatory affairs within the pharmaceutical or biotech industries.
• Skills: Strong knowledge of FDA regulations and ICH guidelines, coupled with excellent communication and team collaboration abilities.
• Mindset: A proactive problem-solver who thrives in cross-functional environments and has a passion for improving healthcare outcomes.

The Senior Manager, Regulatory Affairs' responsibilities will be:

• Strategic Collaboration: Partner with the Senior Director to develop and execute regional regulatory strategies tailored to our initiatives.
• Regulatory Expertise: Lead the preparation and submission of regulatory documents, ensuring alignment with regional and global requirements.
• Cross-Functional Impact: Work closely with product development, manufacturing, and commercialization teams to integrate regulatory considerations into all processes.
• Authority Engagement: Build and maintain relationships with regional regulatory authorities, fostering clear communication and collaboration.
• Continuous Learning: Stay ahead of regulatory developments, providing insights and guidance to support organizational goals.
• Compliance Leadership: Manage post-marketing activities, regulatory risks, and inspection readiness to ensure ongoing success.

Compensation:

• Salary ranges from $160 000.00 - $175 000.00 per annum

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at Write an email

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.