Director/Sr. Director, Regulatory CMC

4 weeks ago

Seattle, United States Just - Evotec Biologics Full time
Director/Sr. Director, Regulatory CMC | Seattle, WA |

Just-Evotec Biologics is seeking a Director/Sr. Director of Regulatory CMC to join a fast-paced, collaborative and multi-disciplinary team to lead all aspects of regulatory affairs for the advancement of low-cost biotherapeutics manufacturing. You will be joining at an exciting time when Just-Evotec Biologics is making game changing advances in biologics discovery, development and manufacturing. The primary responsibilities are to develop and execute global (with an emphasis on US and EU) CMC regulatory strategies towards regulatory adoption of innovative approaches to biologics product and process design, and manufacturing; to lead and manage CMC matters for internal and external products and programs. The Director of Regulatory CMC will have oversight for planning, preparation, and execution of CMC-related communication and documentations for engagement with regulatory authorities. The successful candidate will possess strong interpersonal and team skills to advise and persuade internal and external stakeholders.

Responsibilities:
  • With an emphasis for the US and EU, interpret global CMC regulations and provide strategic direction and regulatory guidance that are relevant to biotherapeutic technologies, products and systems being developed by Discovery, Process Development, Quality and Manufacturing
  • Regulatory input on the design of the J.POD commercial multi-product and multi-modality manufacturing facility
  • Coordinate appropriate meetings such as with the FDA Emerging Technology Team to discuss, identify and resolve potential regulatory issues regarding the design and operations of J.POD manufacturing
  • Lead and coordinate interactions with global regulatory authorities to ensure acceptance, rapid review and approval of applications, supplements/variations and submissions which present CMC information
  • Lead an coordinate authoring of submissions and/or sections of submissions with clients, in-house SMEs and consultants
  • Lead and manage of Chemistry, Manufacturing & Controls (CMC) components for products in early-to-late stage development including novels, biosimilars and cellular therapies
  • Develop innovative strategies and provide Regulatory Affairs input for clients and business partners on all CMC related matters
  • Assure Type V Master File, Letters of Authorizations, and Annual Reporting filings are maintained in accordance with regulatory requirements.
  • Build and scale RA capabilities through creation of a right size internal team and leveraging of consultants and partners
Qualification and Education Requirements:
  • BA/BS degree in molecular biology, cell biology, biochemistry, protein chemistry or similar.
  • Minimum of 8 years of experience in Regulatory Affairs CMC
  • Minimum of 10 years in related disciplines in the pharmaceutical or biotechnology industry in development, quality and cGMP manufacturing
Preferred Qualifications:
  • 15+ years related experience with an advanced degree in related discipline
  • Outstanding interpersonal and communication skills with demonstrated ability to work with cross functional teams comprised of discovery, process development, quality and manufacturing.
  • Experience collaborating with CDMOs, contractors and partners is a plus
  • Experience with preclinical and clinical regulatory affairs topics
  • RAC certification


The base pay range for this position at commencement of employment is expected to be $168,000 to $200,000; Base salary offered may vary depending on individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

  • Senior CMC Leader

    1 week ago

    Seattle, WA, United States Evotec Group Full time

    Director/Sr. Director, Regulatory CMC |  Seattle, WA | Just-Evotec Biologics is seeking a Director/Sr. Director of Regulatory CMC to join a fast-paced, collaborative and multi-disciplinary team to lead all aspects of regulatory affairs for the advancement of low-cost biotherapeutics manufacturing. You will be joining at an exciting time when Just-Evotec...

  • Director, Regulatory Affairs

    2 days ago

    Seattle, United States Imbria Pharmaceuticals Full time

    Company Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...

  • Sr. Account Director, Sales

    18 hours ago

    Seattle, United States e-Rewards Full time

    E-Rewards Services Inc Sr. Account Director, Sales Seattle , Washington Apply Now The Dynata Account Director role exists to drive profitable and sustainable business growth for our most important clients so that the clients would not consider taking their business elsewhere. We adopt a strategic and disciplined approach to managing accounts and set and...

  • Director of Philanthropy

    7 days ago

    Seattle, United States American Rivers Full time

    Job AnnouncementTITLE: Director of PhilanthropyCLASSIFICATION: Director IIDEPARTMENT: Advancement WAGE CATEGORY: Exempt REPORTS TO: Sr. Director of PhilanthropyLOCATION: Remote, Northern Rockies or Pacific NorthwestABOUT AMERICAN RIVERS American Rivers is championing a national effort to protect and restore all rivers, from remote mountain streams to urban...

  • Senior Director, Account Management

    12 hours ago

    Seattle, United States PMI WW Brands LLC Full time

    PMI WW Brands LLC Senior Director, Account Management Seattle , Washington Apply Now ABOUT USThe world's most beloved brands don't just have customers, they have fans - communities of loyal advocates willingto show and share their brand love.At tms, ourGlobal Merchandise Services team helps brands supply their fan communities with covetable merchandise that...

  • Sr. IT Director

    3 weeks ago

    Seattle, Washington, United States Charlie's Produce Full time

    Overview: Charlie’s Produce - Who We Are Charlie's Produce is a privately owned wholesale produce company. We are the largest privately owned produce wholesaler on the West Coast, and we are growing. The secret to our success in this industry is PEOPLE! We strive to hire the best and we reward them with a working environment that fosters loyalty,...

  • Director Quality Assurance

    3 weeks ago

    Seattle, United States Undercurrentnews Full time

    Aqua Star is a privately-owned, American seafood company headquartered in Seattle, Washington. Founded in 1990 by seafood experts who still manage the business today, we are a part of a Family of companies that is collectively one of the largest seafood companies in the world. Position Summary: Aqua Star (USA) Corp. is looking to fill the role of a Director...

  • Site Director

    4 weeks ago

    Seattle, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionSite DirectorThe Site Director will ensure study enrollment to meet or exceed Sponsors' expectations, and company goals are achieved on a timely basis. The site director will also ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations and ICH/GCP...

  • Government Relations Director

    4 days ago

    Seattle, United States Elevance Health Full time

    Government Relations Director Location: Seattle, WA Candidates must reside within 50 miles or 1-hour commute each way of a relevant Elevance Health location. Elevance Health supports a hybrid workplace model (virtual and office) with PulsePoint sites used for collaboration, community, and connection, with the minimum in-office commitment being 1-2 days in an...

  • Sr. Director of Transportation Systems

    14 hours ago

    Seattle, United States Weee! Full time

    **Sr. Director of Transportation Systems** at Weee! Inc Seattle, Washington, United States ****About Weee!**** and , and . Weee! is headquartered in Fremont, CA and currently available coast to coast with exceptional growth (6x YoY) across geographies, categories and ethnicities. We have raised $400M+ in funding to date from leading investors including ,...

  • Director, Risk Adjustment

    4 weeks ago

    Seattle, United States Community Health Plan of Washington Full time

    ** Director, Risk Adjustment** **Job Category****:** Accounting & Finance **Requisition Number****:** DIRRI01579 Showing 1 location **Job Details** **Description** **Job Summary** The Director, Risk Adjustment drives corporate success in achieving outstanding quality of care for our members by providing sharp and timely analytics and insight....

  • Director of Production/Technical Director

    1 month ago

    Seattle, United States Pacific Northwest Ballet Full time

    The Technical Director is responsible for the planning, management, and supervision of all stage and rehearsal work associated with mounting and running of PNB productions. This includes management of Production Department staff and stagehands, and collaborating across departments.

  • Director of Production/Technical Director

    1 month ago

    Seattle, Washington, United States Pacific Northwest Ballet Full time

    The Technical Director is responsible for the planning, management, and supervision of all stage and rehearsal work associated with mounting and running of PNB productions. This includes management of Production Department staff and stagehands, and collaborating across departments.

  • Director of Partner Solutions

    19 hours ago

    Seattle, United States Truveta Full time

    Director of Partner Solutions Truveta is the world's first health provider led data platform with a vision of Saving Lives with Data. Our mission is to enable researchers to find cures faster, empower every clinician to be an expert, and help families make the most informed decisions about their care. Achieving Truveta' s ambitious vision requires an...

  • Director - Labor Relations

    1 week ago

    Seattle, United States Darigold - Northwest Dairy Association Full time

    The Director, of Labor Relations is responsible for shaping and executing Darigold's labor strategy, workforce planning & HR projects. This includes leading collective bargaining and ensuring compliance with all applicable laws and regulations. The D Labor Relations, Director, Relations, Leadership, Department Leader, Support, Manufacturing, Business...

  • Director of Infrastructure

    4 weeks ago

    Seattle, United States Pikemann LLC Full time

    Benefits and Perks: Good starting salary (Annual Base) 100% covered benefits for employee 401 (k) + Benefits + (PTO and observe 11 holidays) $215 per month commuting stipend Offers $$$k for relocation Quarterly Bonus: Manager/Director of Infrastructure Interested? Please send your CV to marco@pikemann.com Pikemann is looking for a Manager/Director of...

  • assistant director for outreach

    3 weeks ago

    Seattle, Washington, United States University of Washington Full time

    As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem-solving skills and dedication to build stronger minds and a healthier world. UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique...

  • Vibrant Life Director

    1 day ago

    Seattle, United States Solstice Senior Living at Normandy Park Full time

    Job DescriptionJob DescriptionActivities (Vibrant Life) Director SUMMARY of Duties The Vibrant Life® Director is responsible for organizing, planning, facilitating and directing the overall operations of the Vibrant Life® Department in accordance with current standards, guidelines and regulations, company policies and procedures, and as may be directed by...

  • Director of Technology

    1 week ago

    Seattle, United States Sellen Construction Full time

    DescriptionEnvision Yourself as a Director of Technology The Director of Technology will lead Sellen's technology operations and program management teams. The Director of Technology defines and communicates the service level requirements for technology and works with the business to establish effective risk management and security measures. The Director of...

  • Associate Director, Bioinformatics

    4 weeks ago

    Seattle, United States Exact Sciences Full time

    Location field must contain 'city, state' or a zip code to perform a radius search (e.g., Denver, CO or 46122 ). City and state must be separated by a comma followed by a space (e.g., Houston, TX ) Exact Sciences Corporation Associate Director, Bioinformatics in Seattle , Washington Help us change livesAt Exact Sciences, we're helpingchange how the world...