Regulatory Scientist/Specialist Job at MSD in Cork
GRACS CMC – Regulatory Scientist/Specialist, P2 – Pharm/Biologics/Vaccines
The Regulatory Scientist/Specialist in GRACS is responsible to support CMC regulatory activities for Our Company’s products in accordance with global regulations and guidelines, and is responsible for technical content input and coordination of CMC submissions for all assigned activities.
Product responsibilities may be in small molecules, biologics or vaccines and could be in the development or the marketed product phase of a drug product life cycle.
Primary responsibilities include, but are not limited to:
Provide scientific input into project regulatory strategy(ies) by ensuring robust assessment of scientific content and critical evaluation of supporting regulatory documentation to confirm acceptability and identification of potential risks.
Actively collaborate with all CMC and cross functional partners to develop innovative regulatory strategies to support submission and approval of new products or lifecycle change to facilitate effective and efficient approval and delivery to the patient.
Support the CMC Product Team on assigned products and be accountable for the delivery of all assigned regulatory activities.
Support technical content writing and review in CMC documentation including IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations and responses to health authority questions per established business processes and systems.
Identify, communicate and escalate potential issues to GRACS CMC product lead and ensure appropriate recording and classification of risks.
Develop an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval, product launch and maintenance of market supply of our company human medicinal products worldwide.
Conduct all activities with an unwavering focus on compliance, including staying current on all training.
Carry out all assignments to the standards of efficiency, innovation, accuracy and safety in accordance with company and regulatory requirements.
Additional activities may be assigned by the supervisor.
Bachelor’s (minimum) or graduate degree (Ph.D. preferred) in a biological science, engineering, or a related field. Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry or other similar scientific discipline.
At least three (3) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields for candidates with a Bachelor’s degree, or one (1) year with a Master’s degree. This requirement is waived for candidates with a Ph.D. degree.
The candidate must be proficient in English; additional language skills are a plus.
Demonstrated understanding of the principles of physical/organic chemistry, biochemistry, engineering/design, physical pharmacy & materials science to evaluate practical pharmaceutical problems.
The ideal candidate will have the ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.
The candidate must demonstrate scientific curiosity, exemplified by a passion to continue to learn and by proactively identifying areas of self-development and growth.
The candidate should have strong technical leadership skills, as well as an understanding of related chemical and pharmaceutical operations (e.g., drug substance or drug product manufacturing, process development, analytical, quality assurance).
The candidate must demonstrate the ability to develop innovative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities.
The candidate must have superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role. The candidate must have excellent interpersonal, verbal and written communication, presentation, and listening skills.
As a company we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.
OUR COMMITMENT TO IRELAND
In Ireland we are one of the country’s leading healthcare companies, having first established here over 50 years ago. We currently employ over 2,200 people, across four sites in Ballydine, Co Tipperary, Brinny, Co Cork, Carlow and Dublin and, in addition, operate substantial Human Health (Commercial) and Animal Health businesses. To date, we have invested $2.5 billion in our Irish operations and our annual turnover ranks us as one of Ireland’s top 20 companies. Currently, our Irish sites manufacture approximately half of our companies top twenty products, saving and enhancing lives around the world.
Our Brinny site in Cork is a leading facility for the development, testing and manufacturing of new biologics and vaccines, exporting to over 90 countries across the world. With a team of approximately 500 people, the Brinny site specialises in the late-stage development and commercial supply of biotech products, including some of the company’s most successful and life-changing treatments for oncology, hepatitis C and rheumatoid arthritis.
The Brinny site has been a vibrant part of the local Innishannon community for nearly 35 years and is now one of the region’s largest employers. The Company has invested €130m in the site since 2016 as a result of increased global demand for medicines and vaccines which will see the Brinny site further expand its production facilities and capacity to meet this demand.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Flexible Work Arrangements:
1st – Day
Valid Driving License:
Number of Openings:
Company Location: Cork