Regulatory Affairs Manager Biologics – Philadelphia, PA

Are you an expert in biologics regulatory strategy with a passion for innovation and compliance? We are seeking a Regulatory Affairs Manager to join a leading biopharmaceutical company in Philadelphia, PA. This is a unique opportunity to lead regulatory submissions and strategy for groundbreaking biologic products in a fast-paced, science-driven environment. If you excel in interpreting global regulations and guiding cross-functional teams through complex submission processes, this role could be the next big step in your career.

Drive Regulatory Strategy for Advanced Biologics in Philadelphia

A prominent biopharmaceutical company based in Philadelphia, PA is hiring a Regulatory Affairs Manager to support the development and approval of novel biologic therapies. The ideal candidate will have deep experience in regulatory affairs within the biologics space, with a strong understanding of FDA and global health authority requirements. If you’re looking to play a pivotal role in bringing innovative treatments to market while ensuring regulatory compliance, we invite you to be part of this mission-driven organization.

Key Responsibilities of the Regulatory Affairs Manager – Biologics

Regulatory Strategy Development:
Design and execute regulatory strategies for biologic products across all phases of development and commercialization. Ensure alignment with global regulatory expectations while supporting business goals and timelines.

Submission Management:
Lead the preparation, review, and submission of regulatory documents including INDs, BLAs, amendments, and agency responses. Ensure accuracy, scientific integrity, and compliance with FDA and international health authority requirements.

Cross-Functional Collaboration:
Partner with clinical, manufacturing, quality, and R&D teams to ensure timely regulatory input throughout the product lifecycle. Provide regulatory guidance and risk assessments to support development plans and decision-making.

Health Authority Interactions:
Serve as the primary regulatory contact for interactions with the FDA and other global regulatory bodies. Prepare teams for meetings, draft briefing materials, and represent the company in regulatory discussions.

Lifecycle & Labeling Management:
Support post-approval regulatory activities including labeling updates, change control documentation, and periodic reporting. Ensure ongoing compliance and timely submission of variations, renewals, and annual reports.

Regulatory Intelligence & Compliance:
Monitor changes in global regulatory policies, guidelines, and industry trends. Apply regulatory intelligence to adapt strategies, ensure best practices, and maintain up-to-date compliance with evolving requirements.

Documentation & Record-Keeping:
Maintain comprehensive records of all regulatory submissions, correspondence, and approvals. Ensure documentation is audit-ready and aligned with internal SOPs and regulatory expectations.

Team Support & Mentorship:
Provide mentorship to junior regulatory staff, fostering knowledge sharing and professional development. Contribute to a collaborative, high-performance regulatory affairs environment.

Risk Assessment & Mitigation:
Identify regulatory risks associated with product development or changes. Develop mitigation strategies and communicate potential impacts to stakeholders proactively.

Ethical Standards & Quality Assurance:
Uphold the highest standards of ethical conduct and quality in all regulatory activities. Collaborate closely with quality assurance teams to align regulatory submissions with GMP and other compliance requirements.

What the Client is Looking for in You

As the Regulatory Affairs Manager – Biologics, the client is seeking a knowledgeable, detail-oriented professional who excels at navigating complex regulatory frameworks and contributing to the successful development and approval of biologic products. You should be a proactive problem solver with excellent communication skills and a collaborative mindset, capable of managing regulatory activities in a dynamic, science-driven environment.

Extensive Experience in Biologics Regulatory Affairs

The ideal candidate will have a strong background in regulatory affairs specific to biologics, with proven experience preparing and submitting regulatory filings such as INDs, BLAs, and global submissions. You should have in-depth knowledge of FDA regulations and a demonstrated ability to engage effectively with global health authorities.

Strategic Regulatory Mindset

The client values candidates who can develop and execute forward-looking regulatory strategies that align with development timelines and business goals. Your ability to anticipate regulatory challenges and proactively address them will be essential to ensuring project success and timely approvals.

Strong Scientific and Technical Expertise

A solid understanding of biologic product development, clinical trial design, and manufacturing processes is critical. You should be able to translate complex scientific data into clear regulatory narratives and guide internal teams with informed, strategic regulatory input.

Excellent Communication and Cross-Functional Collaboration

This role requires strong interpersonal and communication skills to effectively interface with cross-functional teams, senior leadership, and regulatory agencies. The client seeks a team player who can foster collaboration, provide regulatory training, and contribute to a transparent and efficient development process.

Meticulous Attention to Detail and Documentation

Precision and accuracy are key in regulatory submissions. The client is looking for someone who maintains impeccable documentation, adheres strictly to regulatory standards, and ensures audit-readiness at all times.

Adaptability and Regulatory Intelligence

You should have the ability to stay current on changing global regulatory requirements and industry best practices. The client values individuals who can adapt strategies accordingly and provide leadership in a rapidly evolving regulatory landscape.

Commitment to Compliance and Ethical Standards

A strong commitment to compliance, quality, and ethical conduct is essential. The client expects a regulatory professional who upholds the highest standards of integrity and ensures that all activities meet legal and regulatory expectations.

FAQs About the Role – Regulatory Affairs Manager – Biologics – Philadelphia, PA

1. What are the key responsibilities of the Regulatory Affairs Manager in this role?
As the Regulatory Affairs Manager – Biologics, you will be responsible for developing and executing global regulatory strategies for biologic products. This includes managing the preparation and submission of regulatory filings such as INDs, BLAs, and amendments, maintaining compliance with FDA and international regulations, and serving as the primary liaison with regulatory authorities. You will also collaborate with cross-functional teams to provide regulatory guidance throughout product development.

2. What qualifications and experience are required for this position?
The ideal candidate should have a bachelor’s or advanced degree in a life science, pharmacy, or a related field, along with substantial experience in regulatory affairs, specifically focused on biologics. Prior experience with U.S. FDA regulations and global submission requirements is essential. The client values professionals who have contributed to successful IND and BLA submissions and can interpret evolving regulatory policies and apply them strategically.

3. What technical and interpersonal skills are essential for this role?
You should possess strong scientific knowledge of biologic drug development, excellent written and verbal communication skills, and a detail-oriented approach to documentation and compliance. The ability to collaborate with internal teams and regulatory bodies, manage multiple projects, and work under tight deadlines is highly valued. Strong analytical thinking and the capacity to make informed decisions are also critical.

4. What challenges can I expect in this role?
You may encounter challenges such as navigating complex and evolving regulatory environments, managing tight submission timelines, and balancing cross-functional input during development. Staying current with changing FDA and global biologics regulations, as well as interpreting scientific data for regulatory review, will be integral to your success in this position.

5. What is the impact of this role on the company’s success?
As a Regulatory Affairs Manager, your expertise directly influences product development timelines, approval success rates, and market access. Your contributions will help ensure that biologic products meet all regulatory requirements and reach patients efficiently and compliantly, playing a crucial role in the company’s growth and innovation goals.

6. What is the company’s work environment and culture like?
The company promotes a collaborative and science-driven culture with a focus on innovation, quality, and continuous improvement. You will work in an environment that encourages proactive communication, cross-functional teamwork, and a strong commitment to ethical and regulatory standards. Professional development and knowledge sharing are core to the company’s values.

What Remuneration Can You Expect from This Job?

As a Regulatory Affairs Manager – Biologics based in Philadelphia, PA, you can expect a competitive compensation package that reflects your specialized expertise in regulatory strategy, compliance, and product development for biologics. The package typically includes the following components:

1. Base Salary

The base salary for a Regulatory Affairs Manager in the biologics or biotech industry typically ranges from $120,000 to $170,000 per year, depending on your level of experience, specific therapeutic area expertise, and the size of the organization. Candidates with deep knowledge of FDA regulatory frameworks and a proven track record in biologics submissions may command higher salaries.

2. Performance-Based Bonuses

Most companies offer annual performance-based bonuses tied to key deliverables, including regulatory submission milestones, successful IND/BLA approvals, and overall team or company performance. These bonuses generally range from 10% to 25% of the base salary.

3. Long-Term Incentives & Equity

Some companies, particularly biotech firms and those with early-stage pipelines, offer equity-based incentives such as stock options or restricted stock units (RSUs) to align long-term employee contributions with company growth. While not always guaranteed, these incentives can significantly enhance total compensation, especially in high-growth environments.

4. Benefits Package

Regulatory Affairs professionals can expect a comprehensive benefits package that may include:

Medical, dental, and vision insurance
401(k) with employer match or company-sponsored pension plans
Paid time off (PTO), sick leave, and paid holidays
Health savings accounts (HSA) or flexible spending accounts (FSA)
Disability and life insurance coverage

5. Professional Development & Certification Support

Many employers invest in the continuous development of regulatory professionals by offering:

Tuition reimbursement or stipends for certification programs (e.g., RAC – Regulatory Affairs Certification)
Access to industry conferences, webinars, and advanced training opportunities

6. Relocation Assistance (If Applicable)

For candidates relocating to the Philadelphia area, some companies may provide relocation support, which can include reimbursement for moving expenses, temporary housing, or a relocation bonus.

Total Compensation Potential

When combining base salary, bonuses, long-term incentives, and benefits, total annual compensation for a Regulatory Affairs Manager – Biologics can range from $135,000 to over $200,000. This number may be higher in public companies, high-growth biotech firms, or for candidates with niche experience in complex biologics or global regulatory strategy.

How to Apply

If you are an experienced and detail-oriented regulatory professional with a strong background in biologics, we invite you to apply for the Regulatory Affairs Manager – Biologics position in Philadelphia, PA. This is a critical leadership role in a fast-paced and innovative environment where you will play a key role in regulatory strategy, product lifecycle management, and ensuring compliance with global health authority requirements.

To apply, please submit your resume and a cover letter outlining your experience in:

Regulatory submissions for biologics (INDs, BLAs, CTAs, etc.)
Interactions with FDA and other international regulatory agencies
Regulatory strategy development and implementation
Cross-functional team leadership and collaboration
Ensuring regulatory compliance across clinical and commercial phases

Highlight your success in navigating complex regulatory landscapes, supporting product approvals, and maintaining compliance in an evolving global environment.

This is a unique opportunity to shape regulatory direction for a growing biologics portfolio and contribute to the success of life-changing therapies. Apply now to advance your regulatory career in a high-impact leadership role in Philadelphia, PA.

For more information or to explore similar opportunities, visit our Biologics Recruiting Experts Page.

Job Category: Biologics

Job Type: Full Time

Job Location: Philadelphia

Regulatory Affairs Manager Biologics – Philadelphia, PA