Massachusetts Jobs

usa - manager global regulatory affairs (1st shift).

• cambridge , massachusetts (remote)

• posted today

job details

summary

• $116.13 - $138.17 per hour

• contract

• bachelor degree

• category life, physical, and social science occupations

• reference49063

job details

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!

location: Telecommute

job type: Contract

salary: $116.13 - 138.17 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

The contractor works in a highly matrixed, global product team-oriented environment and ensures close collaboration within the Global Regulatory Affairs CMC & Device organization and with other PDT BU functions and relevant company R&D functions to provide an effective and aligned regulatory CMC strategy and submission approach globally, regionally and locally

The Contractor, Global Regulatory Affairs CMC, PDT BU is responsible and accountable for:

• Defining, coordinating and implementing global CMC regulatory strategies for product-specific development and life-cycle activities

• Providing proactive strategic guidance to the product-specific global regulatory and manufacturing sub-teams for defining global regulatory CMC strategies and objectives pertaining to the development, registration, commercialization and lifecycle management of the drug product in the United States and international markets.

• Manages the CMC regulatory strategy of high quality and compliant regulatory CMC documentation (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as meeting requests and briefing packages) for the assigned product(s) within defined timelines as per R&D and business objectives.

• Advises on regulatory strategies, solutions to scientific problems and interpretation of results in the context of product registration requirements combined with the business need and goals.

• Facilitates the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders.

• Identifies and recommends the most effective CMC regulatory strategies to assure a first-pass regulatory approval of initial application and lifecycle supplements/variations.

• Proactively contributes to the development and implementation of innovative CMC regulatory strategies in close collaboration with relevant stakeholders or functions in line with the company's operating model with the purpose to obtain, maintain and extend company PDT BU product registrations in global markets. Provides proactive guidance and regulatory strategies to support PDT product teams.

• Interfaces with key GMS and PDT BU R&D functions in the preparation, review and approval of regulatory CMC submissions as assigned to product and programs.

• In collaboration with the network strategist, develops and manages timelines supporting regulatory submissions, proactively identifies risks and develops adequate risk management solutions in consultation with cross-functional teams.

• In collaboration with regional and local regulatory colleagues, critically evaluates CMC change controls to ensure all regulatory requirements to implement the change have been fully document in the respective quality management system.

• Provides tactical and strategic regulatory input and guidance, including active participation in problem solving analysis by assessing and proposing alternative solutions to issues and prepare contingency plans while still meeting regulations.

• Maintains an ongoing and interactive relationship with regional and local regulatory teams to assure that all aspects of the company's regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.

• Creates high quality, compliant regulatory CMC documents within defined timelines as per the company's PDT BU objectives.

qualifications:

• The role requires an extensive experience in global pharmaceutical/biotechnological drug development and proven knowledge of the global regulatory CMC environment.

• Extensive experience in authoring and managing components of regulatory submissions

• Excellent knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with FDA.

• Demonstrated ability to develop and implement global CMC regulatory strategies, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with health authorities.

• Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve development and commercial goals.

• Extensive experience in US and/or International Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, drug development and/or expedited regulatory pathways.

skills: CMC, Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.