The positions below may not be a match to your background, however; I'd like to know if you can forward these Regulatory Affairs positions to other candidates that are searching for new challenging opportunities.
A growing pharmaceutical company located in Rhode Island is searching for a
SR. MANAGER and a SR. SPECIALIST in REGULATORY AFFAIRS.
The performance bonus for the Sr. Manager is between 18-22%. The bonus for the
Sr. Specialist is between 10-15%.
The company offers full relocation assistance, including a home purchase program(as long as your house is in good standing, they will buy it out). Salary is commensurate with experience plus 3 weeks vacation and a week of shutdown during Christmas plus paid holidays, plus excellent company benefits including 401K match, etc.
If you are in Regulatory Affairs and have the experience that my client is searching for, then please contact me at 973-850-5149 or email me at hans@protechpharma.com (word format resumes only, PDF's are not accepted)
Feel free to share these two exciting opportunities with other candidates in the industry.
SR. MANAGER, REGULATORY AFFAIRS
Management experience is required for this position
CMC filing experience is required
In conduction with Regulatory Affairs experience, knowledge of chemistry is ideal.
Knowledge of international RA regulations is ideal
Responsible for compiling and reviewing data for regulatory submissions covering the company's products.
PRINCIPAL ACCOUNTABILITIES:
- Prepare, compile and publish regulatory submissions
- Track/update regulatory submissions in US and foreign countries
- Respond to customer inquiries in support of their regulatory filings
- Provide regulatory guidance and support to effected company's departments
- Review change controls for any possible regulatory impact
Job Requirements Minimum Bachelor degree in science preferably PhD in organic chemistry. Two years experience with US CMC filings. Familiarity with foreign filing requirements desirable. Required Experience & Technical Requirements - Knowledge of CMC (Chemistry, Manufacturing & Controls) requirements for Active Pharmaceutical Ingredients (APIs) - required for Drug Master Files and providing support information to NDA/ANDA sponsors.
- Knowledge of chemistry (especially Organic Chemistry) to understand complex chemical reactions and review and approve internal regulatory documents (e.g. Development Reports, Validation Protocols, Investigations).
- Knowledge of FDA Regulatory Requirements relating to Facility Registration, Drug Listing and DMFs - responsibility for updating and tracking various filings and registrations. Eventual responsibility for updating and tracking foreign filings.
- Must possess analytical skills and be detail oriented.
SR. SPECIALIST, REGULATORY AFFAIRS
Submission of IND, NDA and ANDA is required
eCTD experience is required
CMC experience is ideal
This position will have advanced responsibilities in support of the Regulatory Affairs department goals and objectives.
PRINCIPAL ACCOUNTABILITIES:
- Manage regulatory affairs drug product development projects through entire lifecycle - from initiation through commercialization.
- Review drug product labeling components for NDAs and ANDAs.
- Compose, review, and submit to the FDA original INDs, NDAs, ANDAs, supplements, amendments, annual reports, and periodic adverse event reports in both paper and electronic CTD format. Review all chemistry, manufacturing, and controls (CMC) documentation related to submissions.
- Complete electronic publishing of regulatory submissions for submission to the FDA and other regulatory authorities.
- Serve as the regulatory representative on cross-functional teams supporting products throughout the stages of development and commercialization. Ensure regulatory and cross-functional project strategies and submission timelines are in alignment.
- Develop and track regulatory project timelines that incorporate all submission requirements including CMC, clinical, and labeling functions.
- Communicate regulatory requirements and expectations to various contract organizations, including travel for on-site meetings as necessary.
- Serve as the company's representative for industry groups. As needed, travel to face-to-face meetings and communicate decision points and meeting outcomes to senior management.
- Evaluate proposed changes to approved products for potential regulatory impact. Gather required data as needed to defend regulatory filing strategy.
- Contact FDA and other regulatory authorities for review status updates for pending applications and supplements.
- Author and review departmental SOPs, as well as any additional SOPs that may impact regulatory affairs.
- Monitor various websites and publications to gather regulatory intelligence on proposed product pipeline projects and any associated information.
- Perform due diligence audits of applications proposed for transfer from external partners. Review all documentation submitted throughout the lifecycle of the application and request any additional information prior to authorization of the transfer. Job Requirements - BS in science or related field with 10 or more years of applicable US Generic Drug Regulatory Affairs experience.
- Advanced degree preferred.
- US Regulatory Affairs Professional Certification is desirable. Required Experience & Technical Requirements - Experience filing electronic CTD submissions in the US
- Experience with regulatory timeline development and document tracking
- Excellent verbal and written communication skills
- Availability and willingness to travel as necessary |
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