Urwah Admin

Ferring Pharmaceuticals, Inc.

<div><div>Job Description:</div><div>
Regulatory Affairs Associate</div><div></div><div>
At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women&rsquo;s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.</div><div>
Joining our Regulatory team, you will be part of an empowering and collaborative culture where your work plays a key role in ensuring patient safety, regulatory compliance and sustainable access to medicines. By working closely with cross-functional teams and external stakeholders, you will support regulatory excellence, life-cycle management and the consistent maintenance of our portfolio. Your contribution helps ensure that high-quality therapies remain available, compliant and trusted throughout their entire life cycle.</div><div></div><div>
Ferring+You</div><div></div><div>
We are looking for a Regulatory Affairs Associate to join our team and take a key role in regulatory compliance, quality assurance, document governance, and cross-functional business support in line with local regulations and global procedures, reporting directly to the Regulatory Affairs Manager.</div><div></div><div>
Your day at Ferring</div><ul><li><div>
Act as Document Accountable Person (DAP) and Document Controller (DC), ensuring document lifecycle management, consistency, and compliance</div></li><li><div>
Serve as the main local regulatory contact and manage regulatory compliance activities</div></li><li><div>
Coordinate new drug approvals, including dossier preparation, submissions, and follow-up with local Health Authorities</div></li><li><div>
Manage regulatory submissions, variations, renewals, and product lifecycle activities</div></li><li><div>
Support and coordinate regulatory inspections and maintain validity of licenses and certificates</div></li><li><div>
Monitor regulatory intelligence, assess impact, and proactively communicate regulatory changes</div></li><li><div>
Ensure timely and accurate updates in global and local regulatory systems (e-CTD, Veeva Vault, Track Wise, etc.)</div></li><li><div>
Prepare, review, and approve artworks and labeling to support submissions and product launches</div></li><li><div>
Review promotional and non-promotional materials in line with local regulations and global procedures</div></li><li><div>
Support Quality Management System (QMS) implementation and sustainability, including local market release</div></li><li><div>
Support regulatory and pricing applications, including document coordination and pricing data monitoring</div></li></ul><div></div><div>
Behind our collaboration&hellip;There&rsquo;s you</div><ul><li><div>
University degree in Pharmacy</div></li><li><div>
Min. 2-3 years of practical experience in regulatory and quality assurance</div></li><li><div>
Know-how of interactions with regulatory authorities</div></li><li><div>
Experience with e-CTD, Veeva Vault, Track Wise, and pricing is a plus</div></li><li><div>
Eager to learn personality, team player approach, attention to details</div></li><li><div>
Fluent in English language (written and verbal)</div></li></ul><div></div><div>
People come first at Ferring</div><div></div><ul><li><div>
Get inspired from our commitment to advocate for everyone&rsquo;s right to build a family, no matter who you are, where you live or who you love</div></li><li><div>
Our inclusive support package &ndash; &ldquo;Building Families at Ferring&rdquo; provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role</div></li><li><div>
Parental leave for both birthing and non-birthing parents</div></li><li><div>
Extended support on family building journey</div></li></ul><div></div><div>
Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member&rsquo;s contributions. Imagine the power of your career when it&rsquo;s Ferring + You.</div><div></div><div>
Behind our purpose&hellip; There&rsquo;s you</div><div>
If our mission and your vision are aligned, please apply.</div><div>
We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.</div><div></div><div>
Location:</div>
Ferring Turkey</div>

Regulatory Affairs Associate

<div><div>Job Description:</div><div>
Role &amp; Responsibilities: (Key accountability areas) :</div><ul><li>
Supervising and leading Mechanical &amp; Facility maintenance function, Tracking expenses and overseeing the budget for Mechanical &amp; Facility maintenance.</li><li>
Ensuring adhere to the safety policies and procedures, quality metrics (on time investigation closure, corrective action implementation, on time document updates), Pressure vessel testing, Inspection, and other Compliances related to Mechanical and Building/Facility maintenance.</li><li>
Installation and Commissioning of process equipment and Qualification/Validation of Process equipment&rsquo;s</li><li>
Manage all Mechanical &amp; facility maintenance systems and personnel to ensure all work orders are completed within the parameters of the CMMS (Computerized Maintenance Management System) in a timely and quality manner.</li><li>
Coordinated and scheduled all preventative/predictive maintenance activities for all plant equipment, including the building infrastructure.</li><li>
Developed and implemented a preventive maintenance program to monitor costs and equipment efficiency, History cards using a CMMS software application.</li><li>
Overseeing Spares stock and ensure no down time due to spares non availibity availibity.</li><li>
Contract with outside service providers for various facility and equipment-related maintenance needs.</li><li>
Attend daily breakdown and perform root Cause analysis of any Breakdown of Production Equipment&rsquo;s.</li><li>
Monitor MTTR/MTBF and Production lost Hours due to Equipment/facility failures and ensure necessary measures for reduction in Break down</li><li>
Support Facility Expansion projects, Implementation of Maintenance strategy programs and other initiatives for Improvement and cost reduction.</li><li>
Ensure Review/Execution of Validation, SOP preparation, as built P&amp;ID, GA drawings shall be maintained.</li><li>
Coordinate/Ensure completion of Mech/Facility related AMC/Services</li><li>
Lead and develop a team of technicians and engineers, fostering a positive work culture, and promoting continuous learning and professional development.</li></ul><div></div><div>
Required Qualification: B. E. / B. Tech in Mechanical</div><div></div><div>
Experience/ Exposure :</div><ul><li>
15-18 years: Preferably in API/Formulation/FMCG/Automation Industries</li><li>
Exposure on Computerized maintenance management system or SAP</li></ul><div></div><div>
Key Behavioral Skills:</div><ul><li>
Drives Initiatives &amp; Proactive in approach</li><li>
Accountability &amp; Ownership</li><li>
Quality Consciousness</li><li>
Stakeholder Management</li><li>
Safety Orientation</li></ul><div></div><div>
Key Technical Skills:</div><ul><li>
Sound experience on Maintenance of Reactors, Centrifuges, ANFDs, Process Vessels, Vacuum Pumps, Powder Handling/Charging system, Heat Exchangers, Scrubbers</li><li>
Should have exposure on Maintenance of ETP/ZLD equipment maintenance (ATFD, MEE, RO, etc)</li><li>
Should be familiar with Preventive &amp; Predictive maintenance.</li><li>
Sound Knowledge on Project documents like P&amp;ID, PFD, Equipment data sheet, Equipment selection as per process.</li><li>
Should have Basis working Knowledge on Autocad tools</li><li>
Should be Familiar with Preventive and Predictive maintenance, MTBR/MTBF etc</li><li>
Should have Basic Knowledge on cGMP document related to engineering environment and other Good Engineering Practices</li><li>
Should be familiar with Tools used for Root cause identification.</li><li>
Should have Exposure on Computerized maintenance management system or SAP</li></ul><div></div><div>
Additional/ Preferable Skills :</div><ul><li> Good to have exposure Energy Management ISO50001:2018</li><li> Good to have Lean six sigma ,5S, TPM and other exposures.</li><li> Familiar with Project Management tools</li><li> Good to have experience in Building/Facility maintenance activities.</li></ul><div></div><div>
Location:</div>
Ferring India Production</div>

Manager - Engineering & Maintenance

Join Ferring Pharmaceuticals, Inc. and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Ferring Pharmaceuticals, Inc.

ABOUT_COMPANY

Regulatory Affairs Associate

Manager - Engineering & Maintenance