Director, Regulatory
Director, Regulatory
Posted on :
17-05-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
17-05-2025
Job Description
JOB DESCRIPTION
DIRECTOR REGUALTORY
Medical
TheRegulatory 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 crossfunctional teamsincluding Account Project Management Editorial Medical and Creativeto build submission excellence enforce best practices and lead regulatory discussions with clients.
Job Qualifications (Skills/Requirements)
About CalciumCompany
CalciumCompany is redefining what it means to be a modern health communications group. Awardwinning and innovationdriven we specialize in nourishing brands and companies across their entire lifecycle and we do it through a dynamic structure of specialized divisions:
Central to our success is our Integrated Strategy Group where brand medical and engagement strategies come together powered by behavioral science and data analytics.
Were proud of the work we do but were just as proud of the culture weve built. CalciumCompany was recently named one of MMMs 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 youre passionate about making a real difference through creativity strategy and collaboration CalciumCompany may be the place for you.
Benefits & Perks We Offer
This position follows a hybrid work model requiring a minimum of two inoffice days per week.
For U.S. Job Seekers it is the policy of CalciumCompany 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.
DIRECTOR REGUALTORY
Medical
Job Summary
TheRegulatory 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 crossfunctional teamsincluding Account Project Management Editorial Medical and Creativeto 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 agencys primary regulatory operations lead across designated brands ensuring all MLR submissions are accurate complete and fully compliant with clientspecific and global regulatory requirements.
- Maintain and evolve agencywide regulatory operations workflows and SOPs ensuring efficient repeatable and qualitycontrolled 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 clientside 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 brandspecific 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 bestpractice improvements.
- Maintain oversight of brand submission calendars and ensure prioritization and resource allocation aligns with brand needs and submission deadlines.
Job Qualifications (Skills/Requirements)
- Bachelors degree required; degree in Life Sciences Communications English Medical Editing or a related field strongly preferredMOU1
- 5 years of experience in regulatory operations MLR submission management or compliance in a pharmaceutical advertising or healthcare communications agencyMOU2
- Expert knowledge of FDA OPDP and international regulatory standards governing promotional materials for pharmaceutical products
- High proficiency with esubmission 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 crossfunctional 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 fastpaced highvolume environment
- Strong problemsolving mindset with the ability to anticipate regulatory risks and proactively provide solutions
- Clear communicator with excellent interpersonal skills and a teamoriented leadership style
- Demonstrated ability to foster a culture of compliance operational excellence and professional growth
About CalciumCompany
CalciumCompany is redefining what it means to be a modern health communications group. Awardwinning and innovationdriven 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.
Were proud of the work we do but were just as proud of the culture weve built. CalciumCompany was recently named one of MMMs 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 youre passionate about making a real difference through creativity strategy and collaboration CalciumCompany 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 InOffice Days
- Annual Employee Gatherings & InOffice Events
This position follows a hybrid work model requiring a minimum of two inoffice days per week.
For U.S. Job Seekers it is the policy of CalciumCompany 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.
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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