Regulatory Affairs CMC / BLA

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.

Currently looking for a Manager and Director, Regulatory Affairs CMC

Advanced knowledge of regulations, guidance documents and corporate/industry standards and an ability to evaluate same for impact on strategic plans and tactical operations. Good scientific/technical knowledge, provides committed, value-added effort in support of development projects. Must be detail-oriented with good oral and written communications skills; able to supervise the preparation of accurate, clear and concise regulatory documents. Excellent time management skills essential; must be able to multi-task and develop timelines for deliverables. Represents CMC Regulatory Affairs internally and facilitates communication with external parties including health authorities. Possesses advanced leadership skills, mentors more junior level regulatory professionals.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Will have a comprehensive understanding of regulatory requirements including FDA, EMEA, ICH guidelines and relevant government regulations (21 CFR, EU Directive) as they apply to the registration, development, and approval of investigational products as well as post approval changes to marketed products, with an emphasis on Chemistry, Manufacturing, and Controls (CMC) and the regulation of biologics.

Coordinates the preparation of CMC submissions through editing and approval of final draft documents, including review for accuracy, soundness, and regulatory appropriateness.

Responsible for IND maintenance including amendments and annual reports and timely regulatory approval and registration of clinical supplies, including regulatory process compliance.

As the regulatory representative to the cross-functional Core Team, the Director provides regulatory guidance to ensure development activities are compliant with relevant guidelines and government regulations.

Proposes strategy for approval of investigational products and post approval changes for marketed product, communicates departmental consensus strategy to Core Team and/or Manufacturing.
Reviews for regulatory compliance and approves validation protocols and reports, batch records, analytical methods, specifications and finished product labels, etc.

Assesses regulatory impact and approves change controls/requests for development and marketed products.

May liaise with regulatory agencies and facilitate regulatory communications.

The Director may manage the activities of more junior level regulatory professionals

ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE:

Must have 3 – 14 years of Pharmaceutical Industry experience including a minimum of 1-5 years of regulatory or related experience.

Comprehensive knowledge of the drug development process and government regulations/guidelines, including US and international product registration.

Excellent oral and written communication skills including the preparation of moderately complex submissions.

Experience supervising and mentoring junior staff members, including effective work delegation.

BA/BS degree or equivalent experience.

Travel Requirements :  Up to 10% 
Position has Direct Reports:  Yes

Please refer to job code CMS 41470 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