We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Senior Manager, Regulatory CMC
We are currently looking for a Senior Manager, Regulatory CMC to support our Regulatory Affairs team. Candidates should be dependable self-starters who bring with them a high level of ownership over their work, an enthusiastic attitude and a collaborative mindset to support our efforts to provide regulatory and development consulting solutions for pharmaceutical and biotech companies of all sizes.
This position can be based in our Burlington, MA office or fully remote with travel as necessary.
Please apply directly by clicking here.
As a Key Contributor You Will be accountable for the execution of operational as well as managerial tasks in the field of Regulatory CMC. Requires established experience and specific scientific expertise in the sector of human and veterinary medicinal products with special emphasis on the relevant US and Canadian regulatory requirements.
Reports to (title): Head of Regulatory Affairs/Regulatory CMC US
Number of direct/indirect reports: None
Travel expectations (in %): Up to 20%
- Contribute to the development and implementation of client’s regulatory CMC strategy.
- Lead gap analysis projects for client to identify gaps and propose mitigation strategies.
- Lead initiatives for project and timeline management in support of regulatory CMC objectives and projects.
- Author high-quality CMC regulatory submission content of the to support global clinical development, registration, and product life cycle management (INDs, IMPDs, DMFs, ANDAs, NDA/BLA, QOS, etc.)
- Manage regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments on deviations, CAPAs, change controls, etc.
- Contribute to business development efforts including proposals and work estimates.
- Actively participate/lead regulatory CMC infrastructure and capability building, including developing best practices, training tools, and cross-program learning.
- Consult with and provide guidance to PHARMALEX staff and customers regarding quality aspects from drug development up to life-cycle management.
- Develop risk-based CMC strategies following cGMP for 21st Century initiatives and Quality by Design (QbD) principles
- Prepare CMC relevant sections of informative texts for healthcare professionals and patients (SmPC, CCDS, PL, labeling).
- Regulatory agency meeting support including meeting preparation and briefing document creation.
- Perform technical database, internet and literature searches with preparation and evaluation of the search results, review, and evaluation of technical literature.
- Present seminars and lectures internally, for customers and for professional audience with emphasis on quality aspects
- Perform project management tasks, e.g., milestone and budget planning.
- Other duties as assigned
- Bachelors’ Degree in Chemistry or Life Sciences, advanced degree preferred, and 7+ years’ experience; or equivalent combination of education and experience
- Minimum of 7 years of related experience in CMC with strong module 3 writing experience.
- Proven experience in evaluation, preparation, and compilation of quality documentations and/or experience in regulatory processes (IND, NDA/BLA, supplements, annual reports) with special emphasis on quality aspects
- Strong knowledge and experience with Regulatory Affairs US as well as submissions to the FDA
- Lead extensive project reengineering activities and provide consultation related to change management
- Experience with chemical and biological products
- Ability to translate strategic goals of partnerships/customers or internal projects into tactical goals
- Ability to lead project teams including supervision, prioritisation and processing of parallel projects and tasks
- Ability to discuss and align mid-term goals of collaboration on level of client’s department heads
- Structured, analytical, systematic and independent manner
- Ability to adapt under regularly changing conditions
- Very good command of English, written and verbal
- Outstanding organization, analytical, and problem-solving skills
- Excellent written, verbal and presentation communication skills
- Flexible scheduling around core hours
- Paid Vacation & Sick time
- 10 paid holidays (including floating holidays)
- Full benefits package including
- Medical (PPO & HDHP)
- FSA, Dependent Care FSA & HSA Accounts
- Company paid life and AD&D insurance
- Company paid short- and long-term disability insurance
- 401(K) with match
- Parental Leave Policy
- Employee Assistance Program
- Tenure Recognition Program
- Employee Referral Program
- Tuition Reimbursement Program
- Paid volunteer hours
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don’t hesitate to contact us:
Director Human Resources US & Puerto Rico
Agencies only by prior agreement for the specific job opportunity.