SanRafaelRecruiter Since 2001
the smart solution for San Rafael jobs

Manager/Sr Manager, Regulatory Global Labeling

Company: BioMarin
Location: San Rafael
Posted on: November 10, 2019

Job Description:

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. BioMarin s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients lives. Position: Manager/Sr Manager, Regulatory Global Labeling Note: This position will be based in San Rafael, CA SUMMARY This position will be responsible for leading the development, review, and management of US, EU, and International labeling for commercial products. The incumbent will be responsible for assessing and managing labeling changes for lifecycle products and develop new labeling for new products in pre-approval stages. The Reg Global Labeling Manager (GLM) (Manager or Senior Manager based on level of experience) will ensure the appropriate labeling strategies are communicated to project teams; compliant with core labeling and local regulations; ensure the labeling is accurate and of the highest quality; and support implementation of approved labels which may include change management records, document control, QCing documents, translations and verification of translations, and tracking project milestones and status. RESPONSIBILITIES This position will be responsible for: 1. The GLM leads the assigned product labeling teams (PLTs) and supports labeling positions. 2. Close collaboration with subject matter experts on the PLT, Global Regulatory sub-teams, and Senior Management Review Teams to ensure the execution of global regulatory labeling plans are aligned with the global regulatory strategy and with BioMarin s labeling processes and standards. 3. Preparation of labeling content based on source documents such as CSRs, regulatory requirements and other reference documents. 4. Review worldwide labeling against the Core Safety Information and facilitate and track implementation of changes to align with core content. 5. Facilitate the review and approval process within the product labeling teams, including outlining the label history and documentation of team decisions. Provide and maintain background documents outlining the purpose and justifications for labeling changes. This includes local labeling content and global labeling content (CCDS). 6. Manage approved labels in a label management database/corporate system to ensure accurate and up to date labeling is available and accessible at all times. 7. Maintain knowledge of current rules and regulations governing global labeling activities. 8. Receive and collate labeling text from labeling team members and manage labeling content and revision control. Assess text for compliance with labeling requirements and provide team recommendations on appropriate text for labeling content. 9. Reviewing and approving artwork and change control related to labeling activities. 10. Supporting launch and/or release of revised labeling into production. Regulatory Labeling Strategy: * Prepare labeling strategy, reach consensus on global labeling matters, assess impact of regional/local labeling changes on the CCDS, and assist with the preparation of high quality documents to support the creation of the CCDS and/or changes to the local labeling for assigned projects or marketed products. * Represent REG GL as a core member of RA Sub-teams, and Safety Management Teams (SMTs) and work in close collaboration with the Global Regulatory Lead (GRL) and relevant line function expert(s) on creation/maintenance of core labeling documents. Participate on Product Core Teams and present strategic global labeling issues to Regulatory Management on an ad-hoc/issue-driven basis for assigned projects/products. * Provide input on interpretation and implementation of key regional labeling regulations, guidelines, and best labeling practices. Regulatory Labeling Activities: * Document control and distribution of product labels (prescribing information, carton and container labeling) including drafting initial documents, annotations, generate and review of SPL files, prepare final labeling. * Project management role of logistical activities and delivering labeling documents within agreed timeframes. Global Product Information: Create and maintain regulatory compliant, competitive and up to date Company Core Data Sheets for assigned key development projects and marketed products. Ensure adequate reflection of key regional input (e.g. EU, US, International Markets) when developing or revising the CCDS. * Prepare and manage International labeling including tracking differences in local labels to the CCDS, ensuring local requirements are met, and translations are properly executed. * Manage translations and address discrepancies with local partners and linguistic experts, ensuring alignment with source content. * Interactions with RA worldwide: Interact with Regulatory International and regional Partners to ensure timely implementation of global labeling changes in local product information, international consistency with the company s position defined in the CCDS and as established by the PLT, and compliance with local labeling regulations. Guide/ support REG International for all labeling related HA negotiations and participate in labeling negotiation meetings or teleconferences with HAs, as needed. Assess country-specific deviations from the CCDS for assigned key development projects and marketed products. * Regulatory Reporting: Provide RA input to Periodic Safety Update Report (PSUR) and Annual Reports for assigned products. * Launch/Implementation: Review final artworks approve new or revised labeling to be implemented into production. Approve all change requests for revised labeling for assigned projects/products. Provide Supply Chain and QA guidance on labeling implementation requirements. Support first launch into new markets. Excellence and Compliance: * Contribute to global labeling management and continuous improvement initiatives. Review and comment on emerging internal and external guidelines and regulations on regulatory, safety, and legal topics. * Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes. EXPERIENCE Required Skills: 4-6 years, or 2-4 years with Advanced Degree (Masters, PhD, MD), 2+ years in Regulatory Affairs. * Regulatory Affairs experience is essential with direct experience managing labeling submissions and related activities * US and/or EU Labeling experience minimally required and core labeling experience highly desired * Experience and working knowledge with SPL and PLR requirements and/or SPC/PIL and QRD requirements * Excellent writing skills especially suitable for labeling, proven experience in drafting labeling content * Experience with E2E global labeling processes and management of Company Core Data Sheets * Experience in review process, standards, and industry best practice pertaining to labeling * Strong scientific background and/or experience * Working knowledge of medical terminology and drug safety * Proven project management, leading teams from multiple functional areas * Highly organized with the ability to manage complex projects and timelines for all aspects of E2E labeling * Experienced processing and assessing translations of labeling a plus. * Excellent verbal and written communication skills; strong technical writing and presentation skills * Must be able to work as a team member and independently * Strong attention to details required and high-quality work * Fluency in English as business language, additional languages advantageous * Ability to travel (up to 15%) for industry conferences or other business meetings * Flexibility to work occasional nights and weekends as determined by critical Regulatory deadlines Desired Skills: * International labeling experience including Latin America, APAC Regions, and MENA CIS Regions desirable. EDUCATION Minimum requirements BS or MS with requisite experience and demonstrated capability. Science or medical background and advanced degree (MD, Ph D, PharmD) desirable. SUPERVISOR RESPONSIBILITY This position does not have direct reports. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Keywords: BioMarin, San Rafael , Manager/Sr Manager, Regulatory Global Labeling, Executive , San Rafael, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

RN Case Manager with OB Experience
Description: Position: RN Case Manager OB Experience Preferred - - - - - - - - - - - - - -Full-Time with BenefitsHours: Monday - Friday, 8:00 AM to 5:00 PMWorksite: Santa RosaDepartment: MedicalFLSA Status: Non-ExemptReports (more...)
Company: Sonoma County Indian Health Project
Location: Santa Rosa
Posted on: 11/20/2019

Branch Manager Trainee - Entry Level Join The Worlds Largest Car Rental company! Sunnyvale 2069773
Description: Branch Manager Trainee Join our Local Edition Corp HLE as a Branch Manager Trainee Each year, many talented people join HLE, and the best become future Branch Managers of our Local Edition branches. (more...)
Company: NetHire
Location: Sunnyvale
Posted on: 11/20/2019

Associate Director, Compliance
Description: SUMMARY: br br The Associate Director, Compliance provides direct oversight for moderate to complex elements of Pharmacyclics' compliance program. br br RESPONSIBILITIES: br ul br br (more...)
Company: Pharmacyclics
Location: Sunnyvale
Posted on: 11/20/2019

Relationship Manager
Description: Why Tri Counties Bank The opportunities for success in the region are large and varied and we have a fantastic reputation of doing the right thing for our customers.What are we looking for A skilled (more...)
Company: Tri Counties Bank
Location: Sunnyvale
Posted on: 11/20/2019

Catering Sales Manager - Social Market - Palace Hotel a Luxury Collection Hotel San Francisco - (191
Description: Here's To Your Journey with Palace Hotel a Luxury Collection Hotel San francisco The Luxury Collection is a glittering ensemble of locally authentic hotels and resorts from around the world. Our hotel (more...)
Company: Marriott International, Inc.
Location: Oakland
Posted on: 11/20/2019

Partner Account Manager
Description: Are you looking for a place where you can utilize your superior sales savvy and skills And a place where you can allow your experience to shine If so, our sales team work with Intermedia Channel Partners (more...)
Company: Intermedia
Location: Sunnyvale
Posted on: 11/20/2019

Sr. Manager Client Success
Description: About the job:IHA is looking for a passionate Senior Manager, Client Success to support the launch of a large scale, state-wide provider directory product for all health plans and providers in California. (more...)
Company: Integrated Healthcare Association
Location: Oakland
Posted on: 11/20/2019

Program Manager
Description: About German Accelerator br German Accelerator empowers German startups to scale globally. We take high potential companies on a fast-paced learning journey in the world's leading innovation hubs at (more...)
Company: German Accelerator Inc.
Location: Sunnyvale
Posted on: 11/20/2019

Lab Manager / Compounding
Description: Job Summary at Heath First Pharmacy: The pharmacy lab manager will support pharmacological services by leading, stocking, assembling, and distributing medications in our state of the art lab. Under the (more...)
Company: Health First! Pharmacy
Location: Santa Rosa
Posted on: 11/20/2019

Senior Manager Forecasting
Description: General Position Summary/Purpose: The Sr Manager, Forecasting will be responsible for producing patient based demand forecast for launched and future indications to support brand commercial planning efforts. (more...)
Company: AbbVie
Location: Sunnyvale
Posted on: 11/20/2019

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Rafael RSS job feeds