Regulatory Affairs Specialist

Role Summary/Purpose:

• The Regulatory Affairs Leader - Pharma may be involved in Pre or Postmarket duties or both.

• He/she provides subject matter expertise and works with a team of RA professionals to ensure

• Establishes best practices in premarket & postmarket for RA, and ensures accurate &

• optimal submission of regulatory medical product clearance files & postmarket reports that meet

• the requirements of the region or country.

Essential Responsibilities:

• File / Maintain regulatory deliverables

• Analyze & communicate changes and proposed changes to country regulations through Regulatory Intelligence and implement strategies

• Support local regulatory authority / notified body inspections as required

• Educate, train, & advise company professionals to ensure compliance with regulatory requirements

• Coach and mentor other RA professionals

• Create regulatory compliance / project plan with Product RA to ensure all requirements are met for country Regulatory market clearance submissions and liaise with relevant personnel to ensure appropriate timely input is provided for submissions, Communicate with Product RA resources to establish regulatory requirements, including clinical trial data.

• Provide RA support as needed to clinical studies to ensure regulatory requirements are met.

• Partner with Product RA professionals to review advertising and promotion materials for country or regional compliance and approve these as required.

• Act as liaison with external regulatory reviewers to gain rapid approval of submissions.

• Work with appropriate Product RA representative for countries with license expiration

• requirements, to establish plans and deliverables for timely submission for renewal of license.

• Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions through the development, maintenance and improvement of documented processes.

• Reviews new reportable adverse events for country report ability.

• Prepare Recall submissions localize if applicable.

• Prepare Regulatory Authority responses to inquiries; work with the P&L to ensure accurate response.

• Following PSRB decision, review field action information to determine if reportable in local country.

• Support regulatory compliance and optimization of quality system procedures relating to post market reporting through the development, maintenance and improvement of documented processes.

• Act as liaison with external regulatory bodies, as required, to ensure appropriate and timely responses are provided to inquiries regarding product reports.

• Provide evidence of official closure of postmarket actions (e.g. AERs and Recalls) to the P&L.

• Monitor external information for incidents or issues that may involve product; communicate information internally in a timely manner.

Quality Specific Goals:

• Aware of and comply with the Quality Manual, Quality Management System, Quality

• Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.

• Complete all planned Quality & Compliance training within the defined deadlines.

• Identify and report any quality or compliance concerns and take immediate corrective action as required.

• Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility.

• Effectively support implementation & management of current regulatory requirements within area of responsibility.

• Ensure assigned regulatory submissions are accurate, complete and timely.

• NEHPP

Qualifications/Requirements:

• Bachelor's Degree (or internationally recognized equivalent) & minimum of 3 years experience in the pharmaceutical or biotechnology industry or with regulatory agencies; OR minimum of 7 years progressive regulatory affairs experience in pharmaceutical or biotechnology industry or with regulatory agencies, including knowledge & experience applying drug or device laws & regulations for product registration, adverse event reporting, & recalls Ability to prioritize, plan & evaluate deliverables to established strategic goals.

• Proven application of analytical skills in a regulatory environment Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research.

• Strong problem solving and negotiation skills

• Ability to work well independently & in a team setting.

• Prior experience using spreadsheet and presentation software.

• Must be willing to travel up to 10% of time.

Desired Characteristics:

• IND, NDA or related submission experience.

• Regulatory Affairs Certification (RAPS).

• Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health

• Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.

• Knowledge of Quality Management Systems (QMS)

• Experience with working across cultures/countries/sites

• Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.

• Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.

• Experience with adverse event reporting and recalls.

• Orphan drug or generics experience.

If you are interested, please feel free to contact me:

Ujjwal Mane
973-805-7557

ujjwal.mane(at)collabera.com