ReciBioPharm, the biologics business unit of Recipharm AB, is a visionary contract development and manufacturing organization (CDMO) that partners with companies seeking to develop and manufacture complex biological drugs and innovative therapies. Our dedicated team, state-of-the-art facilities, and unparalleled resources are crucial for advancing products from development to commercial launch. Our vision is to be the trusted and innovative CDMO partner for advanced therapy pioneers, so that we can bring life-changing therapeutics to patients. We partner with our clients to make treatments that can benefit vast patient populations, working across many indications. ReciBioPharm’s mission is to change healthcare through our intrepid and daring team engaging with clients to develop, manufacture, and supply breakthrough therapies that transform lives.
The Director of Regulatory CMC will be based either virtual or based in Watertown or Boxboro Massachusetts and will be responsible for generating and managing regulatory submissions for the company (CMC content only) as well as working with and advising customers as to CMC strategy best practices to support their regulatory submissions. This position will support all regulatory activities in multiple jurisdictions (US and EU) to provide high quality CMC sections of regulatory documentation. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. This role will report to the Chief Quality and Regulatory Officer.
ESSENTIAL JOB FUNCTIONS
- Develop and support effective CMC regulatory strategies for submissions
and identify regulatory risks
- Develop CMC modules/updates, including life cycle management,
generation of submission-ready content for customer’s clinical trial and
marketing authorization applications, and management of timelines, and
submission planning activities
- Forecast, manage, plan, and coordinate internal review of CMC
documentation for submissions and amendments, and other
communications with international regulatory authorities (e.g., briefing
documents for CMC meetings)
- Develop and maintain current CMC regulatory knowledge in
countries/regions of interest based on ICH guideline, regional guidance,
and best practices to set Reg CMC strategies for program teams.
- Play a key role in defining strategy for impurity control and establish
platform-based, phase appropriate specifications, analytical method
- Manage preparation and internal review of high quality Module 2 (QOS)
and Module 3 documents for IND/CTA/NDA/MAA as appropriate
- Interface with customers regarding regulatory CMC strategy and
development of content for regulatory submissions
- Author processes and SOPs in relation to regulatory operations and in
connection with other cross-functional procedures to achieve regulatory
submissions compliance and management
Experience and Skills
- B.A./B.S. degree in life sciences, MS is preferred
- 8+ years of direct experience in regulatory affairs specifically in CMC
documentation and CMC lifecycle management within the pharmaceutical
or biotechnology industry is a must;
- Experience in ATMPs early to late development phases required
- Experience in formatting, preparation and submission of CMC modules in
eCTD format, including variations and supplements, in the US and
- Excellent organizational skills, written and interpersonal communication
- Ability to lead and work with others in a collaborative and empowering
- Working knowledge of regulations of worldwide health authorities and ICH
- Proficient use of MS Office and project planning tools
- Very good prioritization skills to balance key priorities
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The employee is frequently required to stand; sit; use hands to finger,
handle, or feel; reach with hands and arms; and talk or hear.
- The employee is occasionally required to walk; climb or balance; and
stoop, kneel, crouch, or crawl.
- The employee must frequently lift and/or move up to 10 pounds and
occasionally lift and/or move up to 25 pounds.
- Specific vision abilities required by this job include close vision, and
ability to adjust focus.
- In the performance of the duties of this job the employee is required
to travel occasionally, drive a motor vehicle.
- Communicate using telephone and e-mail.
Who We Are
ReciBioPharm hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.
Here at ReciBioPharm, we embrace ALIVE – our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging. Are you ready to come ALIVE with a daring and intrepid team? Don’t wait another minute; Apply today!
- This position requires a criminal background check and drug screening.
- COVID19 Vaccine required to come on site; Individuals seeking an exemption from this requirement for medical or religious reasons should reach out to Human Resources for an accommodation.
ReciBioPharm offers a very competitive benefits package including medical, dental, vision, prescription drug coverage, life and disability insurance, 401(k), and generous vacation and time off policies among other attractive benefits. We operate in a world class facility to attract the best and brightest talent to work collaboratively in our mission to bring novel therapies to the patients who need them most.
ReciBioPharm is an Equal Opportunity Employer.