WE ARE LOOKING FOR A REGULATORY AFFAIRS MANAGER FOR A HIGH-SPEED MANUFACTURING COMPANY IN SOMERSET NJ starting pay $130-$135k.
MUST BE LOCAL TO THE FACILITY NO RELOCATION FOR THIS ROLE.
- MUST HAVE: In-depth knowledge of ISO 15378:2017 standard or equivalent
This is a This is a new position to provide technical and compliance assurance in order to grow and develop the companies market share in pharmaceutical packaging.
We are looking for a Regulatory Affairs Manager to develop and monitor the company's activities with regards to applicable regulations and standard operating procedures. The Regulatory Affairs Manager will be primarily focused on pharmaceutical packaging compliance and supporting customer interactions. Candidates will be comfortable working independently as well as collaboratively while being a positive reflection of corporate values.
- RESPONSIBILITIES: Safety Responsibilities:
- Supports a culture where employees address unsafe conditions and behaviors, make suggestions for improvements, and actively participates in implementing solutions
- Identifies safety gaps and self-initiates corrective actions
- Strictly adheres to plant safety, housekeeping, and 5S efforts
- Understands, identifies, and corrects safety hazards
- Drives a culture which empowers employees to understand and embrace what they own
- Food Safety Responsibilities:
- Monitors and verifies activities to ensure that finished goods and raw materials are coming in and out of the facility meet consumer safety and quality standards.
- Complies with all company food safety and quality assurance procedures
- Reports any product or process failures that could impact food safety of manufactured product to the location's Food Safety Team Leader and submits an appropriate incident report
- Additional Job Responsibilities:
- Follows Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) as applicable
- Supports expansion of market share of pharmaceutical business with customer facing activities
- Trains staff in regulatory policies and procedures
- Develops strategy to ensure the company's activities comply with government agencies and applicable industry requirements.
- Responds to requests for information from customers and applicable regulatory agencies
- Assists with the development of standards for the company's operating procedures to assure compliance with relevant regulatory requirements.
- Maintains current knowledge of regulations and industry practices applicable to the company
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes
- Develops and maintains professional relationships with applicable regulatory agencies, customers, and suppliers
- REQUIRED SKILLS / ATTITUDES:
- Strong customer satisfaction orientation
- In-depth knowledge of ISO 15378:2017 standard or equivalent
- In-depth knowledge of pharmaceutical industry
- In-depth knowledge of applicable government regulations
- Above average communication skills and interpersonal skills
- Able to manage projects and prioritize tasks
- Excellent analytical and problem-solving skills
- Excellent listening skills along with highly effective written and verbal communication skills
- High technical proficiency including expertise in Microsoft Office Suite, including but not limited to Word, Excel, PowerPoint, Visio, and Outlook
- A high level of trustworthiness and the ability to achieve integrity on all levels
- Ability to manage multiple tasks or projects with patience and tenacity
- Self-motivated and self-disciplined