Director Regulatory CMC jobs in Milford, PA
Recently Added Director Regulatory CMC jobs
Device Regulatory Lead (Associate Director)
- Sanofi
-
Swiftwater, PA
FULL_TIME
-
Our Team:
The Global Regulatory Affairs Device team is a globally diverse team supporting the medical device, combination product, digital health and in-vitro diagnostic products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global R&D.
Position Overview:
Sanofi’s global regulatory affairs (GRA) function is comprised of more than 1800 people. The Device Regulatory Lead for Specialty Care & Vaccine Combination Products will oversee key regulatory activities and report to the GRA Device Team Leader for Specialty Care & Vaccine Combination Products, who in turn reports to the Head of GRA Device. The candidate will work within a matrix environment, operating as a strong independent contributor on assigned projects. The role will represent the GRA Device perspective as a member of project specific cross functional global regulatory team (GRT) and is accountable to develop and maintain device aspects of project regulatory strategy documents.
The incumbent will provide strategic and tactical support on Sanofi’s combination product portfolio and will also have the opportunity to work on other innovative projects. The incumbent will work closely with key stakeholders including clinical, medical affairs, Industrial Affairs (Device Development, manufacturing, quality, supply chain) and drug product development. Combination product and drug delivery device systems technology is often exploring new territories that need “new” thinking and approaches from a regulatory perspective. The incumbent will be expected to proactively initiate discussions with regulatory authorities and contribute to industry standards and guidelines. The incumbent has a patient- and quality-focused mindset and drives a culture of continuous improvement in compliance with Sanofi’s behavioral and ethical standards.
This critical and highly visible position offers the successful candidate the opportunity to support a wide range of combination products, from pre-filled syringes, autoinjectors, pumps and other innovative combination product technologies, all of which are part of Sanofi’s exciting development pipeline.
Key Responsibilities:- Serve as Device Regulatory Lead on assigned project teams (early phase, late stage and marketed products).
- Develop innovative and sustainable medical device regulatory strategies covering combination products and delivery systems (device elements).
- Provide regulatory guidance and advice to development teams.
- Prepare regulatory design control deliverables.
- Review and approve design control deliverables.
- Lead and/or support global filing activities for device aspects of combination product submissions.
- Contribute to product development planning, including strategies to bridge delivery systems during development.
- Identify and manage issues and opportunities that impact submissions timelines; ensures appropriate communication, resolution and/or escalation as needed.
- Ensure regulatory plans are monitored, progress/variance communicated to Management and any risks are highlighted.
- Lead and/or support device related health authority interactions.
- Provide regulatory impact assessments for proposed product changes.
- Work closely with internal and external partners to ensure regulatory risks are identified, communicated, and properly addressed.
- Contribute to internal regulatory processes and procedures for medical devices and combination products.
- Engage with the relevant regulatory bodies and industry groups to influence industry standards and regulations, ensuring that Sanofi’s best interests are represented.
- Sound understanding of and experience with global regulatory requirements for combination products and delivery systems.
- Working knowledge with technical/industry standards related to drug delivery systems, such as autoinjectors, pumps, etc.
- Solid understanding of regulations and guidelines related to drug development and registration.
- Proven ability to work cross-functionally in a highly professional global environment.
- Bachelor’s degree in a scientific or engineering discipline with at least 6 years of relevant combination product regulatory experience or a combination of a Master’s degree relevant experience.
- At least 10 years experience in the global healthcare industry.
- Proven experience in drug/device combination product regulatory approvals.
- Demonstrate strategic thinking, initiative, change agent leadership and risk assessment proficiency, including ability to integrate overall business objectives into actionable project strategies.
- Ability to synthesize and critically analyze data from multiple sources.
- Dynamic personality, ability to think outside the box.
- Demonstrates excellent communication and influencing skills internally and externally and in particular the ability to impact and influence decisions on global teams, both written and verbal, in English.
- Strong interpersonal skills and the ability to deal effectively with a variety of business areas including medical, scientific, and manufacturing.
- Demonstrate strong organizational skills, including the ability to prioritize workload and capacity to work under pressure.
- Ability to travel internationally (minimal).
- An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
- An individual and well-structured introduction and training when you onboard
- You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully
- As a globally successful and constantly growing company, Sanofi provides international career paths as well
At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
- 8 Days Ago
Regulatory Strategist
- Sanofi
-
Swiftwater, PA
FULL_TIME
- About The JobOur Team:The team is involved in developing and executing regulatory strategies for rabies vaccines in post marketing and in development stages to support the Traveler Endemic Franchise b...
- 11 Days Ago
Hair Stylist - Viewmont Mall
- CMC Markets
-
Scranton, PA
PART_TIME
- General DescriptionAt JCPenney Salon, we strive to unlock the potential of America’s top salon professionals, creating an unparalleled experience for our clients today, tomorrow and for life. Every da...
- 7 Days Ago
Omnichannel Associate - Viewmont Mall
- CMC Markets
-
Scranton, PA
PART_TIME
- General DescriptionAs the Omni Associate you are accountable for contributing to profitable sales growth by executing Enterprise Fulfillment and jcp.com activities and strategies to include Customer S...
- 7 Days Ago
Cashier - Viewmont Mall
- CMC Markets
-
Scranton, PA
PART_TIME
- General DescriptionAs a Cashier you are accountable for the customer service and sales experience including: maintaining checkout standards; assisting with general operations such as Omnichannel, reco...
- 8 Days Ago
Sales Floor Assistant - Viewmont Mall
- CMC Markets
-
Scranton, PA
FULL_TIME
- General DescriptionAs the Sales Floor Assistant, you are accountable for driving customer service to achieve profitable sales growth by leading and engaging associates, managing company merchandise st...
- 8 Days Ago
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0 Director Regulatory CMC jobs found in Milford, PA area
EXECUTIVE DIRECTOR
- Suburban Emergency Medical
-
Easton, PA
- Job Description Job Description Description: Suburban Emergency Medical Services is an EMS leader in the Lehigh Valley a...
- 6/8/2024 12:00:00 AM
Director of Operations
- Plastic Executive Recruiters
-
Scranton, PA
- Job description MUST HAVE - Other "related" experience will not be considered. PVC Pipe fittings (injection molded or ex...
- 6/7/2024 12:00:00 AM
Director of OBGYN
- Tal Healthcare
-
Monroe, NY
- Job Description Our client, a community-based health center providing primary and specialty care committed to providing ...
- 6/6/2024 12:00:00 AM
Library Director
- Port Jervis Pub. Library
-
Port Jervis, NY
- The Port Jervis Free Library (PJFL) seeks a creative, dynamic, and inspiring new Library Director. PJFL is a School Dist...
- 6/4/2024 12:00:00 AM
Activities Director (Resident Life Director)
- Belle Reve Senior Living
-
Milford, PA
- SAME DAY PAY available! If you would like to work in a positive environment and use yourtalents and experience to make a...
- 6/4/2024 12:00:00 AM
Resident Care Director or Director of Nursing - RN
- Sunrise Senior Living
-
Mountain Lakes, NJ
- Overview The Resident Care Director (RCD) serves as the nursing clinical leader for the community and is responsible to ...
- 5/31/2024 12:00:00 AM
Director, Strategic Carrier Relations
- ADP
-
Parsippany, NJ
- ADP is hiring a Director, Strategic Carrier Relations Are you an experienced professional with a deep understanding of t...
- 5/21/2024 12:00:00 AM
Director, Engineering
- Great Wolf Lodge
-
Scotrun, PA
- Pay: $90000 per year - $90000 per year At Great Wolf, the Director of Engineering sets the vision and managing the effec...
- 3/22/2023 12:00:00 AM
About Milford, Pennsylvania
According to the United States Census Bureau, the borough has a total area of 0.5 square miles (1.3 km2), all land.
Milford is located on the Upper Delaware River, which divides Pennsylvania's Poconos region from the Catskill Mountains in New York, in what was historically a heavily forested area. When Judge Biddis bought up the land of what was then known as Wells Ferry and laid out the lots for the new town, he generally followed the urban plan of Philadelphia: he laid out High Street – the equivalent of what is now Market Street in Philadelphia – running to the Delaware River, while Broad S...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Director Regulatory CMC jobs
$213,949 to $321,728
Milford, Pennsylvania area prices
were up 1.5% from a year ago
were up 1.5% from a year ago