GRA CMC Specialist

CSL•Waltham, MA

About The Position

The Team Lead, Global Regulatory Affairs CMC - Biological & Non-Biol. Products is responsible for: Partnering closely with CSL’s R&D, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the assigned product portfolio. Defining global regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s biological & non-biol. products. Represent CSL in official regulatory CMC capacities, acting as an authorized official or responsible person in interactions with regulatory agencies. This role promotes strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL’s strategic business objectives.

Requirements

A bachelor’s degree in biological or chemical sciences, or a related field is required; an advanced degree (e.g., MS, PhD) is strongly preferred.
Over 5 years of progressive experience in regulatory roles within the biologics or plasma industry, demonstrating increasing levels of responsibility.
Strong technical foundation with in-depth knowledge of global regulations and international standards governing drug product development, manufacture, registrations, and life-cycle management.
Proven expertise in authoring, reviewing, and managing regulatory submissions ensuring accuracy, compliance, and timely delivery.
Demonstrated ability to lead cross-functional teams and collaborate effectively with key stakeholders.
For the Level 6 and Level 7 roles, skilled in motivating, mentoring, and guiding diverse teams within a matrixed organizational structure, fostering a culture of accountability and excellence.
Skilled in motivating, mentoring, and guiding diverse teams within a matrixed organizational structure, fostering a culture of accountability and excellence.
Exceptional oral and written communication skills, with a strong ability to negotiate, influence, and represent regulatory positions effectively.
Committed to the highest standards of compliance, integrity, and adaptability, with a strong focus on aligning regulatory strategy with evolving business needs.
Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve goals.
Ensures Accountability: Follows through on commitments and makes sure others do the same; Acts with a clear sense of ownership; Takes personal responsibility for decisions, actions, and failures; Establishes clear responsibilities and processes for monitoring work and measuring results; Designs feedback loops into work.
Drives Results: Has a strong bottom-line orientation; Persists in accomplishing objectives despite obstacles and setbacks; Has a track record of exceeding goals successfully; Pushes self and helps others achieve results.
Drives Vision & Purpose: Talks about future possibilities in a positive way; Creates milestones and symbols to rally support behind the vision; Articulates the vision in a way everyone can relate to; Creates organization-wide energy and optimism for the future; Shows personal commitment to the vision.
Instills Trust: Follows through on commitments; Is seen as direct and truthful; Keeps confidences; Practices what he/she preaches; Shows consistent between words and actions.
Communicates Effectively: Is effective in a variety of communication settings: one-on-one, small and large groups, among diverse styles and position levels, with internal and external stakeholders/audiences. Attentively listens to others; Adjusts to fit the audience and the message; Provides timely and helpful information to others across the organization; Encourages the open expression of diverse ideas and opinions.
Builds Effective Teams: Establishes common objectives and a shared mindset; Creates a feelings of belonging and strong team morale; Shares wins and rewards team efforts; Fosters open dialogue and collaboration among the team.
Drives Engagement: Structures the work so it aligns with people's goals and motivators; Empowers others; Makes each person feel his/her contributions are important; Invites input and shares ownership and visibility; Shows a clear connection between people's motivators and the organizational goals.
Manages Ambiguity: Deals comfortably with the uncertainty of change; Effectively handles risk; Can decide and act without the total picture; Is calm and productive, even when things are up in the air; Deals constructively with problems that do not have clear solutions or outcomes.
Collaborates: Works cooperatively with others across the site, matrix, network and enterprise to achieve shared objectives; Represents own interests while being fair to others and their areas; Partners with others to get work done; Credits others for their contributions and accomplishments; Gains trust and support of others.
Decision Quality: Makes sound decisions, even in the absence of complete information; Relies on a mixture of analysis, wisdom, experience, and judgment when making decisions; Considers all relevant factors and uses appropriate decision-making criteria and principles; Recognizes when a quick 80% solution will suffice.
Global Perspective: Looks toward the broadest possible view of an issue or challenge; Thinks and talks in global and network terms; Understands the position of the organization within a global, network and enterprise context; Knows the impact of global trends on the organization.
Being Resilient: Is confident under pressure; Handles and manages crises effectively; Maintains a positive attitude despite adversity; Bounces back from setbacks; Grows from hardships and negative experiences.

Nice To Haves

an advanced degree (e.g., MS, PhD) is strongly preferred.

Responsibilities

Lead the global regulatory CMC strategy across the assigned development and commercial biological & non-biol. product portfolio, collaborating closely with cross-functional leaders in Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, Global Operations, and other business functions.
Manage the development and submission of high-quality, compliant CMC regulatory submissions and submission components, including new marketing applications, clinical trial applications, variations/supplements, periodic compliance reports and renewals. Ensure timely execution aligned with regulatory expectations and business goals.
Ensure accurate and timely change control assessments of change control notifications in CSL’s quality management system for biological & non-biol. product-related change controls. This includes the country-specific reporting category and detailed submission documentation requirements.
Leverage external insights to refine strategies and implement innovative regulatory approaches that enhance CSL’s competitive positioning for its biological & non-biol. product portfolio.
Represent CSL in official regulatory CMC capacities, acting as an authorized official or responsible person in interactions with regulatory agencies. Maintain strong, positive relationships with regulators and ensure timely responses to inquiries and requests. Facilitate timely decision-making and guidance from health authorities through effective communication and relationship management.
Develop strategic and tactical plans for Global Regulatory Affairs CMC, advising Global Regulatory Affairs CMC leadership and CSL stakeholders on regulatory requirements and their implications for project timelines, compliance, and business strategy. Contribute to the evaluation of new business opportunities in collaboration with development teams.
Provide regulatory consultation to internal CSL functions, including Global Operation functions, R&D, and IT, to support the design and implementation of business processes that ensure regulatory compliance and operational excellence.
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.
Ensure regulatory policies and procedures are developed and implemented in accordance with applicable international standards and requirements. Support the creation and execution of regulatory policies, processes, and SOPs that meet global regulatory requirements while driving operational efficiency and effectiveness across Global Operations and its stakeholder network.
Support the outsourcing of regulatory activities, including submission quality assurance, to ensure timely and compliant delivery of services aligned with business and regulatory requirements.