Manager - Regulatory Affairs

Job Context:

To support MIBG I-131 clinical programs and other JDI innovative products in the pipeline, The Regulatory Specialist will be reporting to the director of Regulatory Affairs and support the development of regulatory strategies related to JDI clinical programs, marketing applications in US and Canada and post-marketing activities.

Challenges:

3. SCOPE and SIZE OF THE ROLE (Please indicate key metrics defining the size and scope of the role)

Revenue / Operating Budget

As per JDI RA budget plans

Geographical Responsibilities (Global / International / Country / Area with in Country

Will work with the team in Canada and based out of India

Area of Impact (Dept. Location / Function or Business / Organization)

Regulatory Affairs

;;;;;;;;;;;;;Accountabilities ;;;;;;;;;;;;;;;;;;;;;;;;;;;Scope of work

• Regulatory Support

Support regulatory due diligence activities pertaining product in-licensing or acquisition (product in clinical development or approved products).

Re-evaluate the regulatory strategies following major changes including but not limited formulation, clinical protocol and marketing changes.

Participate actively to meetings with regulatory agencies (pre-submission phase, NDA/NDS review phase, post-approval phases)

Prepare, review and submit USFDA Investigational New Drug Application (IND) and Health Canada Clinical Trial application (CTA) filings to include but not limited to: new protocols applications, clinical protocol amendments, informed consent forms, clinical summary reports, regulatory correspondences, deviations, safety reports, cost recovery applications, exemptions, CMC amendments.

External Interfaces

Internal Interfaces

Regulatory Agencies

Clinical sites, Quality, marketing, clinical, technical services and R and D departments

Indicate the education level, previous experience, specific knowledge, skills and abilities required to meet minimum requirements for this Job..

Education Qualification(Highest )

with Target Institute(s)

Bachelor's degree in biology, biochemistry, or other life science

Desired Certifications :

A minimum of 5 years of related experience.

Experience Range :

10 - 12 years

No. of years post Highest Qualification :

8 years

Desirable experience :

10 to 12 Years of Industrial Experience

;;; Skills

Description

Proficiency Level

(General Awareness; Working Knowledge; Functional Expert, Mastery )

Functional Skills

Must be detail-oriented with well-developed organizational and analytical skills

Functional Expert

Behavioral
Skills

Must be self-motivated, capable of managing multiple projects in a fast-paced environment.

• General Awareness: Knows the fundamental or general understanding of concepts.
• Working Knowledge: Has broad job knowledge; knows and applies the full range of concepts and practices. Has broad / working knowledge of the subject. Candidate should use these concept in day to day practices.
• Functional Expert: Candidate is certified functional expert with strong knowledge on concepts.
• Mastery: Candidate is subject matter expert and has command over the subject/ concepts.