Regulatory Affairs Specialist I
Bachem. Pioneering Partner for Peptides
Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe and the US, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership.
The Regulatory Affairs Specialist I is responsible for assisting with the preparation of submissions to national and international regulatory agencies. This includes the preparation of drug master files submissions and amendments, annual reports, and any related correspondence and letters of authorization.
Essential Functions and Responsibilities:
- Assist with compilation of drug master files for active pharmaceutical ingredients and other substances
- Prepare annual reports for regulatory submissions
- Maintain records of regulatory submissions and associated letters of authorization
- Maintain records of correspondence with regulatory agencies and customers related to regulatory submissions
- Assist with DMF amendments
- Assist with technical data packages for active pharmaceutical ingredients and other substances for use by customers in the preparation of their own submissions
- Bachelor’s Degree in Science related field (Chemistry, Biology or equivalent)
- 1-2 years of experience in cGMP manufacturing, Quality Control, or Quality Assurance
- Technical writing experience
- Excellent written and oral communication skills
- Basic computer knowledge, including Microsoft Word, Excel, PowerPoint and Access
- Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
- Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
- Detail oriented with the ability to troubleshoot and resolve problems
- Ability to work independently and manage one’s time
- Communicate effectively and ability to function well in a team environment
What We Offer
An exciting opportunity to dive in and begin your career with a company that offers a competitive total rewards package that includes:
- Full range of health benefits including medical, dental, vision and long-term disability
- 401(K) Safe Harbor Plan (3% company contribution, 100% vested)
- iPay Incentive Plan
- 11 Paid Company Holidays, Personal Time, Sick Leave and Vacation Time
- Travel to Switzerland for certain key positions
- Company sponsored events! (Summer BBQ and Holiday Party)
- Generous product discounts
Bachem recognizes that highly motivated and well-qualified employees are its most important asset. The competence, motivation and performance of individuals and the team are key to the development and long-term success of our business. We therefore strive to attract, retain and develop talented and committed people to all of our Group Companies. Bachem ensures equal opportunities for its employees and will not tolerate any discrimination.
This position requires the employee to regularly stand, walk, sit and talk or hear. The employee must also be capable of writing, using a computer keyboard, telephone and related office equipment. The ability to lift up to 25 lbs. is required.
The physical demands 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.
Within the facility, the employee will experience normal office conditions with a well- lighted work area and minor noise from standard office equipment. Occasionally the employee will experience unpleasant odors from the manufacturing facility. On a daily basis, the employee will visit the manufacturing facility several times. Lab coat and goggles will be required for these visits. The employee will constantly experience laboratory hazards. Very occasionally, the employee will be called upon to address emergency situations.