Manager, Regulatory Operations / Submissions

Located in central NJ, this is a biopharmaceutical company dedicated to developing breakthrough biologic medicines in the area of oncology. The Company has utilized the many advances made in the fields of molecular biology, oncology, genomics, and antibody engineering to build a novel pipeline of product candidates designed to address specific genetic mechanisms involved in cancer growth and development.

Their goal is to become a fully-integrated biopharmaceutical company that has the capability and resources to take its novel pipeline compounds and develop them from the research and development stage through to commercial manufacture, marketing and sales.  With their first innovative cancer drug on the market and late stage clinical candidates soon to be, they have cooperative agreements with several big pharmaceutical companies to help market their drugs. A solid, fast growing midsized company which incorporates the best of both worlds, security with room to grow.

                            Currently looking for a Manager, Submissions Management


GENERAL SUMMARY:
The incumbent is accountable for handling specific responsibilties within the scope of the Submissions Management group under Regulatory Operations. The Manager is responsible for managing submission assignments from planning to delivery and developing/maintaining the processes, deliverables, execution and skills to ensure quality and compliance for all Submissions Management activities.

The candidate works directly with various stakeholders within the Regulatory Affairs and with other appropriate internal departments (Clinical Affairs, Non-clinical, Manufacturing, Information Technology, Human Resources, Finance and Legal) or external third-party organizations pertaining to the scope of the assignment(s). As a management representative of Regulatory Operations, the candidate is expected to exhibit professional behavior to foster conducive working relationships, enhance the departmental culture and aid in the development of high performance teams.

The candidate must be detail-oriented and a team player as well as being proficient in time management and knowledgeable with business processes. The expectation is that the candidate should work effectively with some supervision. The candidate should be competent with problem solving, decision making and project management while having the capability with critical and strategic thinking, mentorship and leadership skills in team scenarios.

RESPONSIBILITIES:
1.Proficient with annual reporting and routine maintenance planning as well as knowledge of maintenance processing for guidance and quality control.
2.Collaborates and negotiates deliverables across project matrix teams, third party vendors and/or development partners to ensure effective project communication and coordination for assignments.
3.Responsible for managing team members and quality control of business function components within assigned role (routine or major submissions) to meet timelines and to provide quality deliverables.
4.Assesses business trends, pending regulations and emerging technology for critical thinking with business strategy and development roadmap.
5.Participates in the strategic planning, development and implementation of processes and/or technology alignment with assigned functional role(s).
6.Develops work instructions and ensures compliance to departmental SOPs while monitoring conformance to guidance and regulations from Health Authorities to enhance productivity.
7.Maintains competent knowledge for current/emerging regulations, guidance documents and corporate/industry standards for their impact on strategic plans and tactical operations.
8.Assists in problem solving and decision making for conflict management and process management.
9.Assists in the assessment of budget needs within assigned role and maintains competence with Finance and Legal processes for procurement and contracts respectively.
10.Assists with Senior Management requests from Regulatory CMC & Operations or Regulatory Affairs as needed.

ESSENTIAL KNOWLEDGE,
SKILLS, EXPERIENCE:
1.Must have 3-5 years of pharmaceutical industry experience with a minimum of 2 years of regulatory submissions experience.
2.Bachelor Degree or equivalent experience. Demonstrated US Regulatory submission experience at a complex level is required.
3.Must have working knowledge of the drug development process, Health Authority regulations and guidance documents (US, EU, CAN) and ICH technical aspects of product registration.
4.Capable knowledge in developing and managing SOPs and work instructions.
5.Competent knowledge of CTD/eCTD in both regulatory and technical perspectives.
6.Experience with managing people with tasks and/or projects.
7.Knowledge with process development and compliance to SOPs and Work Instructions. Working knowledge with industry best practices and standards.
8.Must have excellent communication skills and be able to establish and maintain relationships with various intra-department, inter-department, and external third party personnel.
9.Demonstrated experience with Company critical skills: Self Assessment & Awareness, Managing

Please refer to job code 414190 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Bridgewater, NJ
County:	Somerset County
ZIP Code:	08807
Pay Rate:	Competitive
Job Terms:	full time
Company:	Discovery Solutions, Inc.
Phone:	(443)402-1582
Fax:	410-510-1240