Director, Regulatory

Philadelphia, PA

Full Time

Amino

Experienced

JOB DESCRIPTION
DIRECTOR, REGUALTORY
Medical

Job Summary

The Regulatory Director oversees all regulatory operations and compliance processes related to medical/legal/regulatory (MLR) submissions across multiple pharmaceutical and healthcare brands. This individual ensures that all agency deliverables meet client, regulatory requirements and submission protocols. The Regulatory Director partners with cross-functional teams—including Account, Project Management, Editorial, Medical, and Creative—to build submission excellence, enforce best practices, and lead regulatory discussions with clients.

Key Job Responsibilities (Duties may include, but are not limited to all or some of the following)

Serve as the agency’s primary regulatory operations lead across designated brands, ensuring all MLR submissions are accurate, complete, and fully compliant with client-specific and global regulatory requirements.
Maintain and evolve agency-wide regulatory operations workflows and SOPs, ensuring efficient, repeatable, and quality-controlled processes for submissions across all business units.
Lead the development, execution, and refinement of submission protocols, reference tagging/linking standards, and claims documentation in alignment with FDA/OPDP and international regulatory expectations.
Establish and maintain strong relationships with client-side MLR teams to facilitate smooth and successful submissions, proactively resolving process or content issues.
Oversee submission strategy planning in partnership with Account and Project Management leads, providing guidance on timelines, regulatory feasibility, and submission readiness, while working closely with Editorial and Copy teams to ensure alignment with references and sourcing
Directly manage or oversee the QC, tagging, linking, referencing, and uploading of materials in regulatory platforms (e.g., Veeva Vault PromoMats, Zinc, Aprimo), ensuring accuracy and completeness of submission packages.
Guide the creation and maintenance of reference libraries, claims lists, annotated references, and brand-specific submission checklists, delegating effectively to appropriate team members.
Represent Regulatory Operations in internal leadership meetings, client business reviews, and new business pitches as needed.
Monitor changes in regulatory policy, client requirements, and industry trends; proactively advise executive leadership and brand teams on compliance risks or best-practice improvements.
Maintain oversight of brand submission calendars and ensure prioritization and resource allocation aligns with brand needs and submission deadlines.

Job Qualifications (Skills/Requirements)

Bachelor’s degree required; degree in Life Sciences, Communications, English, Medical Editing, or a related field strongly preferred [MOU1]
5+ years of experience in regulatory operations, MLR submission management, or compliance in a pharmaceutical advertising or healthcare communications agency[MOU2]
Expert knowledge of FDA, OPDP, and international regulatory standards governing promotional materials for pharmaceutical products
High proficiency with e-submission platforms such as Veeva Vault PromoMats, Zinc, and PubMed
Skilled in Adobe Acrobat, Microsoft PowerPoint, Word, Excel, Outlook, and OneNote
Strong understanding of reference tagging, linking, annotation standards, and claims substantiation best practices
Familiarity with digital and omnichannel materials and how they intersect with MLR workflows
Leadership & Strategic Skills
Proven ability to manage cross-functional teams and collaborate with executive leadership, client stakeholders, and external partners
Exceptional organizational skills and attention to detail, with the ability to prioritize competing deadlines in a fast-paced, high-volume environment
Strong problem-solving mindset with the ability to anticipate regulatory risks and proactively provide solutions
Clear communicator with excellent interpersonal skills and a team-oriented leadership style
Demonstrated ability to foster a culture of compliance, operational excellence, and professional growth

About Calcium+Company

Calcium+Company is redefining what it means to be a modern health communications group. Award-winning and innovation-driven, we specialize in nourishing brands and companies across their entire lifecycle — and we do it through a dynamic structure of specialized divisions:

Calcium (healthcare marketing)
Amino (oncology marketing)
Vitamin MD (medical communications)
PRotein (public relations)
Cobalt (commercial planning and market access)

Central to our success is our Integrated Strategy Group, where brand, medical, and engagement strategies come together, powered by behavioral science and data analytics.

We’re proud of the work we do, but we’re just as proud of the culture we’ve built. Calcium+Company was recently named one of MM+M’s 2024 Best Places to Work, reflecting the authentic, supportive, and inspiring environment in which our team thrives.

Led by CEO Judy Capano and Group President Greg Lewis, we are a company where you can build extraordinary campaigns and a nourishing career.

If you’re passionate about making a real difference through creativity, strategy, and collaboration, Calcium+Company may be the place for you.

Benefits & Perks We Offer 

Paid annual vacation, personal and sick time off
11 Paid Company Holidays
Paid Holiday Closure: Agency closed between Christmas and New Years
Comprehensive health plans, including medical, dental, and vision
Flexible spending accounts (Healthcare & Dependent)
Competitive 401(k) investment with company match
Life & AD&D Insurance
Commuter Benefits
Employee Referral Bonus Program
Employee Assistance Program
Telemedicine Services
Voluntary Benefits (Pet Insurance, Identity Theft Protection, Legal Services)
Summer Fridays
Emphasis on Social Impact: A variety of specialized employee resource groups (PMCGs), programming and other initiatives.
Lunch Credit for In-Office Days
Annual Employee Gatherings  & In-Office Events

This position follows a hybrid work model, requiring a minimum of two in-office days per week.

For U.S. Job Seekers, it is the policy of Calcium+Company to provide equal employment opportunities to all employees and applicants for employment without regard to race, religion, color, ethnic origin, gender, gender identity, age, marital status, veteran status, sexual orientation, disability, or any other basis prohibited by applicable federal, state, or local law.

EOE/AA/M/D/V/F.

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Director, Regulatory

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