Sr. Director, Regulatory Affairs CMC - Replimune, Inc.

The Senior Director, CMC Regulatory Affairs reports to the VP, Regulatory Affairs and develops and executes CMC regulatory strategies and activities. This includes oversight of the development and implementation of global regulatory strategies, ensuring timely preparation, review and submission of CMC documents to regulatory authorities, oversight of the preparation of meeting requests and briefing documents to obtain regulatory advice, collaborating with development partners, and maintaining compliance with applicable regulatory requirements. This position will work in partnership all Regulatory subject matter experts (SMEs) to co-develop a fully integrated regulatory strategy.

This position can be based in our Woburn office which welcomes hybrid work!  Local candidates are expected to be on-site 2 days per week. it can also be staffed remotely 

Key responsibilities:

• Help build, develop, lead, and drive the overall CMC regulatory strategy for the company’s product pipeline that ensures scientific value creation across lifecycle towards initial approval, launch, and label expansions.
• Provide leadership and guide the overall CMC regulatory strategy for all programs from early development through regulatory submissions and post-commercialization, with an emphasis from mid to late stages of development.
• Influence strategy to address internal or external business and regulatory issues and proactively identify potential strategic issues and opportunities.
• Drive and execute the CMC regulatory activities that lead to successful IND/CTA and global marketing filings for new cancer therapies.
• Identify, assess, and communicate potential risks associated with development and regulatory strategy scenarios and plan risk mitigation strategies.
• Interact directly with global regulatory agencies and ensure that interactions are properly communicated to the CMC teams and/or business partners. Triage, coordinate and manage responses to questions from regulatory authorities by collaborating with the CMC teams to address regulatory agency feedback and define long and short ranged actions.
• Responsible for the coordination, timely preparation, review and submission of CMC documentation packages for regulatory agency interactions (e.g., FDA pre-/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/scientific advice, etc.).
• Develop submission plans and timelines for CMC and in partnership with all other Regulatory SMEs for coordination.
• Direct or manage resources of the authoring and preparation of CMC sections as applicable.
• Review product development and technical documentation for regulatory compliance and inclusion in submissions to FDA and foreign regulatory agencies.
• Work collaboratively on cross functional teams, including process development, manufacturing, supply chain, quality, and regulatory to manage activities and/or changes related to product development, manufacturing, and commercialization.
• Manage external regulatory consultants and project deadlines.
• Ensure compliance with company standards and the applicable US and international regulations.
• Evaluate deviations, change controls and product incident documents for impact on submissions and filing requirements.
• Review product labeling for clinical trial and commercial labeling.

Other responsibilities:

• Contribute to initiatives to improve processes within the Regulatory department.
• Develop and maintain current regulatory knowledge and keep up with/implement the changes required for regulatory compliance.
• Review SOPs and protocols with regard to regulatory matters.
• Perform other appropriate administrative duties, such as preparing correspondence and filing, where necessary.
• Maintain regulatory documentation including submissions to and correspondence with each governing authority.
• Provide mentoring to staff and have skill sets for directly managing staff.

Educational requirements:

• A or B.S. degree, MS preferred, in an appropriate scientific field with 15+ years’ experience in Pharmaceutical/Biotech Industry with 10+ years in a CMC Regulatory Affairs capacity.

Experience and skill requirements:

• Strategic leader with demonstrated success building, managing and developing teams is required
• Professional knowledge and skills working with solid tumor oncology therapeutics is required with biologic, gene therapy, or vaccine experience preferred.
• Team player with senior presence and demeanor coupled with excellent written and verbal communication skills as well as outstanding analytical abilities but with a willingness to be hands on and does not delegate responsibilities.
• Previous experience in representing the sponsor in front of regulatory agencies and as primary regulatory author for IND and CTA documents in preparing regulatory submissions (IND, BLA, CTA, etc.) to the FDA and EU Regulatory Authorities
• Expedited approval pathway, rare disease, and commercial experience preferred
• Highly knowledgeable in ICH, FDA and EMA regulations and guidelines and experience working in a global environment
• Skilled in multiple computer-based tools, in addition to software programs such as MS Office Expertise: Outlook, Word, Excel, PowerPoint, Project, Visio
• Strong interpersonal, organizational, and time management skills with attention to detail
• Ability to work independently and manage multiple projects in a fast-paced environment
• Capable of handling matters of strict confidentiality and sensitivity
• Appropriate GMP or GXP training
• Prior experience with vendor selection and management is expected.
• Experience with the development and support of related SOPs and policies is expected.
• Experience with partnerships and strategic alliances is expected.
• Ability to relate and work with a wide range of people to achieve results.
• Impactful written and verbal scientific communication skills.
• Successful and superior influencing skills across all levels of the organization and with external collaborators.
• Problem solving and risk-mitigation skills.
• Ability to build working relations throughout the organization and with business partners to achieve business goals.
• Ability to travel approximately 15% of time.

Location Requirements

This position can be either based in our Woburn Corporate office which maintains a hybrid schedule, or it can be staffed remotely 

About Replimune 
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.