Ad/Director, Regulatory Affairs CMC

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company's pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases.

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation - TRUE Innovation!

Position Summary:

The AD/Director, Regulatory Affairs CMC (Chemistry, Manufacturing and Controls) will be responsible to ensure that Zenas is executing global regulatory CMC strategies to support clinical development and commercialization readiness of biologic drug products and drug/device combination products. The individual will provide regulatory guidance and contribute to the development and implementation of short and long-term regulatory strategies for assigned projects and programs. The individual will be responsible to lead the writing and reviewing of CMC sections of regulatory submissions (IND/IMPD/BLA) to meet both global quality expectations and company timelines. The ideal candidate is a Regulatory Affairs CMC specialist with prior experience with biologic drug combination products. The Director, RA CMC participates in a cross-functional team, partners with key internal/external stakeholders in Technical Operations, Quality, and Regulatory Affairs to ensure the scientific data and submissions fulfill agency expectations in a compliant manner. This position will report to the Vice President, Global Regulatory Affairs CMC.

Key Responsibilities:

• Lead the development of the regulatory CMC strategy for assigned development products

• Support development teams and provide direction on the interpretation and application of CMC/Quality regulations and guidance documents.

• Prepare/coordinate/review the CMC content of IND/IMPD/BLA submissions, meeting packages and response to regulatory agency questions and requests.

• Lead teams for assigned CMC submission projects per agreed upon/required timelines.

• Provide strategic and regulatory compliance input on technical protocols, reports, and other source CMC documents.

• Ensure alignment of the regulatory CMC strategy with the corporate objectives through communication and collaboration with internal stakeholders and business partners. Escalate issues to Senior Management that may impact regulatory compliance and continued development of assets.

• Maintain a current knowledge of US and EU regulatory guidance, regulations, and competitive intelligence. Communicate key updates to Senior Management and project teams as appropriate, and ensure Zenas's regulatory submissions comply with all regulations/guidelines.

• Represent Regulatory Affairs CMC on various cross-functional teams.

• Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.

• Perform other regulatory related duties as assigned.

Qualifications:

• A BS, or advanced degree, preferably in life/physical sciences

• A minimum of 8 - 12 years regulatory affairs experience (3+ years RA CMC) within the pharmaceutical or biotechnology industry

• Prior experience in developing US and EU global regulatory strategies for biologic drugs

• Knowledge of biologics development process

• Working knowledge and experience of combination product design and development (prefilled syringes, autoinjectors)

• Prior experience in compiling module 3 CMC sections for IND/IMPDs

• Experience interacting with key functional stakeholders (product development, manufacturing, QA, QC, supply chain)

• Ability to influence across functions and levels within the organization.

• Self-motivated, self-disciplined and able to function independently as well as part of a team

• Ability to prioritize, multi-task, and work in an evolving and high-pressure environment

• Good presentation and excellent written/verbal communication skills

• Ability to work effectively in hybrid model from home (remote) or the company office.

• Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.

#LI-Hybrid

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $152,800 to $215,000.. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas' competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.

Zenas BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.