Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Join Us as a Regulatory Affairs Associate Director – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our global team, you’ll have the opportunity to lead innovative projects and provide strategic regulatory intelligence that makes a real difference in product development. As a Regulatory Affairs Associate Director, you'll play a key role in guiding product development from preclinical stages through registration and optimization. You will provide regulatory expertise and client interface, offering strategic guidance and updates on country, regional, and global regulatory intelligence. Routinely act as an adviser to other units within the department and liaise with local country regulatory authorities. Responsible for acting as a liaison with internal and external clients in the provision and marketing of these services.

What You’ll Do:

Lead CMC regulatory strategy and submissions for biologicals, ensuring compliance and successful product approvals across different regions.

This is a position to lead and execute global CMC regulatory strategy and submissions, ensuring the delivery of high-quality CMC dossiers in full compliance with international regulatory standards.

CMC Regulatory Strategy and submissions for Biologicals

• Lead the development and execution of CMC regulatory strategies for biological products across regions.
• Serve as the subject matter expert on biologics, providing CMC regulatory guidance for the preparation of regulatory submissions to the regional agencies.
• Act as the primary liaison for CMC regulatory matters related to biologicals, collaborating with internal teams (R&D, Quality, Manufacturing, Global Regulatory) to align on submission strategies.
• Oversee the preparation, review, and submission of CMC sections (Module 3) specific to biological products, in regulatory filings such as MAAs and variations.
• Author, compile, and maintain CTD Module 3 content as applicable.
• Coordinate responses to CMC-related questions and deficiencies raised by the health authorities during product registration.

Post-Approval Compliance and Lifecycle Management

• Perform change control impact assessment for CMC changes
• Lead the CMC regulatory management and dossier authoring of post-approval changes, including manufacturing process changes, site transfers, and formulation updates for biological products
• Ensure continuous compliance with regulatory requirements throughout the lifecycle of the biological product, managing variations and renewals.
• Monitor and assess regulatory guidance related to biologics and provide strategic input into regulatory filings.

• Acts as a global lead in providing review and technical advice to prepare regional and/or global regulatory submissions and ensure high quality standards that meet or exceed client expectations, local and regional requirements.
• Acts as lead subject matter expert in providing regulatory strategy advice and technical expertise to internal and external clients and oversees key client projects. Provides internal clients with up-to-date legislation and guidance as it becomes available.
• Ensures quality performance for key/managed projects.
• Manages project budgeting/forecasting functions.
• Identifies and recognizes out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
• Collaborates with business development in pricing and securing new business by making presentations to clients, and develops proposal texts and budgets in collaboration with other departments.
• Oversees matrix/project leadership, training and guidance to junior team members.
• Ensures compliance with relevant organizational and department SOPs and WPDs.
• Participates in and leads launch meetings, review meetings and project team
meetings. Leads departmental initiatives/project teams.

Education and Experience Requirements:
• Master degree or PhD in biotechnology, pharmaceutical sciences or bio‐engineering, with relevant expertise in CMC development and CMC regulatory for biological products (min 10 yrs)

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:
• Mastery of English language (written and oral) communication skills as well as local language where applicable
• Exceptional attention to detail and quality as well as outstanding editorial/proofreading skills
• Accomplished interpersonal skills to work effectively in a team environment and act as a liaison with other departments
• Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Effective organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
• Professional negotiation skills
• Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
• Advanced, broad understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; in-depth understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.
• Advanced understanding of medical terminology, statistical concepts, and guidelines
• Outstanding analytical, investigative and problem-solving skills
• Excellent understanding of budgeting and forecasting
• Sharp executive presence and consultation and presentation skills

• Extensive knowledge of global regulations including EMA regulations, ICH guidelines, and specific CMC regulatory requirements for biologics.

• Proven experience leading CMC regulatory submissions for biological products, including initial MAA submissions and post-approval lifecycle management.

• Strong understanding of biologics manufacturing, characterization, comparability, and analytical testing requirements.

• Excellent project management skills with the ability to manage complex projects and timelines.

• Strong communication and interpersonal skills, with experience working in cross-functional and international teams.

Working Conditions and Environment:
• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site locations with occasional travel both domestic and international.