TechData is looking for Regulatory-CMC consultant - Biologics and Regulatory-CMC Technical Writer for our pharmaceutical clients. Please see below requirements and send your resume to: [click here]. TechData is a leading provider for temporary and permanent positions in the pharmaceutical industry. TechData offers the most competitive pay rates and benefits in clinical research consulting services.
Title: Regulatory-CMC consultant - Biologics
DEPARTMENT Regulatory Affairs
Location: San Diego,CA
Duration: One year Long term and renewable
PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with
a minimum of 7 years in the pharmaceutical industry, and a minimum of 5 years CMC regulatory (biologics preferred) experience.
Responsibilities will include, but are not limited to, the following:
1. Responsible for the development of the CMC regulatory strategy for submissions. These submissions include IND/CTA/BLA, NDA, CTD and MAA regulatory filings.
2. Lead the preparation and review CMC submission documents, registration dossiers, health authority briefing packages, and responses to health authorities with other relevant line functions.
3. Interact with regulatory agencies and represent Regulatory CMC at regulatory agency meetings. Prepare SMEs for health authority meetings as required.
4. Responsible for the management of CMC activities related to specific developmental or commercial compounds.
5. Responsible for the regulatory evaluation of CMC change controls.
6. Represent Regulatory CMC on cross-functional teams such as GPDO development/commercial and Regulatory Affairs teams.
7. Take a leadership role in the CMC development/commercial teams.
8. Maintain knowledge of global regulatory environment, regulations and procedures.
§ Must have experience with CMC regulatory documents (NDA, MAA, CTD, BLA, supplements, responses and IND/CTAs)
§ Experience in the development of CMC regulatory strategy with a focus on BLA and global biologic marketing applications.
§ Thorough knowledge of FDA, EMEA and ICH guidelines.
§ Knowledge of rest of world pre- and post-approval guidelines
§ Have a solution-oriented approach to problem solving
§ Expertise in the biologic drug development process and post approval activities
§ Ability to work on complex projects and within cross-functional teams
§ Prior supervisor or project management experience
§ Experience with global CMC regulations for biological compounds.
Title: Regulatory-CMC Technical Writer
Duration: 6 Months and have a chance to extend
• Perform CMC technical writing and editing assignments related to the preparation of CMC components of regulatory submissions and other technical documents such as protocols, reports and procedures, as well as any other documents determined to be within the scope of the role; and ensure that project time-lines are met
• Work cooperatively with colleagues in applicable functions or departments (e.g., R&D, Process Development, Manufacturing, Supply Chain, Regulatory Affairs, Validation, Quality Control and Quality Assurance) and external organizations (e.g., CMO) to ensure achievement of Shire objectives relating to the preparation of CMC regulatory submissions and associated activities such as content verification and risk assessments
• Experience in writing CMC components of regulatory submissions together with knowledge of relevant regulatory agency guidance including ICH, FDA, EMA, and authorities in other major geographic areas is desirable
• Detail oriented and articulate with ability to write in a precise, clear style
• Excellent communication skills, written and verbal
• Excellent organization skills
• Strong team member with demonstrated ability to work collaboratively with others as well as being able to take initiative and exercise independent judgment
• Proficient in use of Windows environment software with advanced skills in Microsoft Word